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Diagnostica Stago, Inc.
Diagnostica Stago, Inc.: 26 FDA recall reports
Every medical device recall the FDA has published for Diagnostica Stago, Inc.. The fault, and how the agency graded it.
26Reports
0Class I
12Ongoing
2026-03-25Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Descrip
Z-1585-2026 · Class II · reported 2026-03-25 · Ongoing
- Why it was recalled
- After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
- Product
- Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative determination of D-dimer in venous plasma for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia.
- How much
- 34000 units (28446 US, 5554 OUS)
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF):
Z-1491-2026 · Class II · reported 2026-03-11 · Ongoing
- Why it was recalled
- The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
- Product
- Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable
- Where it went
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MI, MN, MO, MT, NC, ND, NJ, NY, OH, PA, TN, TX, UT, VA, WA and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BIELORUSSIE, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COSTA RICA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, GUATEMALA, INDIA, IRAQ, IRELAND, ITALY, JORDAN, KENYA, KOREA REPUBLIC OF, LITUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PAKISTAN, PALESTINIAN TERRITORY, PARAGUAY, PORTUGAL, ROMANIA, RUSSIE, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIE, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY;
- How much
- 369
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative d
Z-1084-2026 · Class II · reported 2026-01-21 · Ongoing
- Why it was recalled
- Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
- Product
- Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.
- Where it went
- Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, HI, IA, MA, MI, NJ, NV, NY, OH, TN, WI and the countries of Belgium, Canada, Denmark, Algeria, Spain, Finland, France, Great Britain, Italy, Lebanon, Saudi Arabia, Uganda.
- How much
- 438 units
Product: STA Liatest D-Di; REF: 00515;
Z-0205-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
- Product
- Product: STA Liatest D-Di; REF: 00515;
- Where it went
- Worldwide distribution- US Nationwide and the country of Canada.
- How much
- 12740 units
STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use wit
Z-2474-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
- Product
- STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
- Where it went
- Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, France, French Polynesie, Guadeloupe, India, Iran, Israel, Jordan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Oman, Paraguay, Peru, Republique Tcheque, Romania, Saudi Arabia, Serbia, South Africa, Switzerland, Taiwan, Thailand, Tunisia, Turquie, United Arab Emirates, Uruguay, Vietnam.
- How much
- 116,600 units (114,600 US)
STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated
Z-2473-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
- Product
- STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
- Where it went
- Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, France, French Polynesie, Guadeloupe, India, Iran, Israel, Jordan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Oman, Paraguay, Peru, Republique Tcheque, Romania, Saudi Arabia, Serbia, South Africa, Switzerland, Taiwan, Thailand, Tunisia, Turquie, United Arab Emirates, Uruguay, Vietnam.
- How much
- 3,650 units (538 US)
STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use wi
Z-2475-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
- Product
- STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
- Where it went
- Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, France, French Polynesie, Guadeloupe, India, Iran, Israel, Jordan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Oman, Paraguay, Peru, Republique Tcheque, Romania, Saudi Arabia, Serbia, South Africa, Switzerland, Taiwan, Thailand, Tunisia, Turquie, United Arab Emirates, Uruguay, Vietnam.
- How much
- 126,200 units (125,900 US)
STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the a
Z-2476-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
- Product
- STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of Clauss.
- Where it went
- Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, France, French Polynesie, Guadeloupe, India, Iran, Israel, Jordan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Oman, Paraguay, Peru, Republique Tcheque, Romania, Saudi Arabia, Serbia, South Africa, Switzerland, Taiwan, Thailand, Tunisia, Turquie, United Arab Emirates, Uruguay, Vietnam.
- How much
- 829,800 units (245,200 US)
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as
Z-1993-2025 · Class II · reported 2025-06-25 · Ongoing
- Why it was recalled
- Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
- Product
- STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.
- Where it went
- The affected lot was distributed to customers in various US states in October and November 2024. The lot was also distributed in other countries including Canada. The lot was provided to two Distributors in US Territories: MedPharm Corp (Guam) and Isla Lab Products (Puerto Rico); MedPharm will be notified by Stago's Asia-Pacific business unit in the coming days and is not part of this report.
- How much
- 939 US ( 2,810 total worldwide)
STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
Z-1576-2023 · Class II · reported 2023-05-17 · Ongoing
- Why it was recalled
- An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).
- Product
- STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
- Where it went
- US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.
- How much
- 2 analyers
STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
Z-1577-2023 · Class II · reported 2023-05-17 · Ongoing
- Why it was recalled
- An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).
- Product
- STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
- Where it went
- US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.
- How much
- 5 analyzers
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59
Z-1575-2023 · Class II · reported 2023-05-17 · Ongoing
- Why it was recalled
- An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).
- Product
- STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
- Where it went
- US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.
- How much
- 6 analyzers
STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended f
Z-1699-2020 · Class II · reported 2020-04-22 · Terminated
- Why it was recalled
- A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased
- Product
- STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989, 58990 (B) STA-R Evolution, Product Codes: 58986, 58987, 58988 (C) STA Compact Max, Product Codes: 59026, 59027 (D) STA Compact, Product Codes: 58978, 58979
- Where it went
- Nationwide
- How much
- 3,225 units
STA SYSTEM CONROL N + P (ref. 00678)
Z-0738-2020 · Class II · reported 2020-01-01 · Terminated
- Why it was recalled
- A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
- Product
- STA SYSTEM CONROL N + P (ref. 00678)
- Where it went
- US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK
- How much
- 5,437
STA UNICALIBRATOR (ref. 00675)
Z-0737-2020 · Class II · reported 2020-01-01 · Terminated
- Why it was recalled
- A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
- Product
- STA UNICALIBRATOR (ref. 00675)
- Where it went
- US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK
- How much
- 5,498
Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for th
Z-0611-2019 · Class II · reported 2018-12-26 · Terminated
- Why it was recalled
- There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
- Product
- Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
- Where it went
- US Nationwide Distribution
- How much
- 22342 total
Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the
Z-0610-2019 · Class II · reported 2018-12-26 · Terminated
- Why it was recalled
- There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
- Product
- Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
- Where it went
- US Nationwide Distribution
- How much
- 22342 total
Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin t
Z-2994-2018 · Class II · reported 2018-09-19 · Terminated
- Why it was recalled
- QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
- Product
- Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA¿ - N¿oplastine¿ CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
- Where it went
- Nationwide
- How much
- 5 kits
Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothro
Z-2993-2018 · Class II · reported 2018-09-19 · Terminated
- Why it was recalled
- QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
- Product
- Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
- Where it went
- Nationwide
- How much
- 24043 kits
STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrom
Z-1069-2018 · Class II · reported 2018-03-21 · Terminated
- Why it was recalled
- Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
- Product
- STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
- Where it went
- Nationally
Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin t
Z-1067-2018 · Class II · reported 2018-03-21 · Terminated
- Why it was recalled
- Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
- Product
- Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).
- Where it went
- Nationally
STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin t
Z-1068-2018 · Class II · reported 2018-03-21 · Terminated
- Why it was recalled
- Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
- Product
- STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
- Where it went
- Nationally
Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin ti
Z-1066-2018 · Class II · reported 2018-03-21 · Terminated
- Why it was recalled
- Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
- Product
- Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
- Where it went
- Nationally
- How much
- 1636 Kits
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R
Z-2650-2014 · Class III · reported 2014-09-24 · Terminated
- Why it was recalled
- Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
- Product
- Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
- Where it went
- Distributed USA (nationwide) and the country of Canada.
- How much
- 514 kits
Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnost
Z-0951-2013 · Class II · reported 2013-03-20 · Terminated
- Why it was recalled
- Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
- Product
- Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asni¿res sur Seine (France) Coagulation Assay
- Where it went
- Worldwide Distribution - USA and Canada.
- How much
- 2901 kits
STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indic
Z-0252-2013 · Class II · reported 2012-11-14 · Terminated
- Why it was recalled
- Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite¿.
- Product
- STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
- Where it went
- Worldwide Distribution - USA (nationwide) and Canada
- How much
- 232 units US; 5 units Canada
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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