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Randox Laboratories Ltd.
Randox Laboratories Ltd.: 79 FDA recall reports
Every medical device recall the FDA has published for Randox Laboratories Ltd.. The fault, and how the agency graded it.
79Reports
0Class I
31Ongoing
2024-07-31Most 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.
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on a
Z-2425-2024 · Class II · reported 2024-07-31 · Ongoing
- Why it was recalled
- Cystatin C Reagent marketed without a 510 (k)
- Product
- RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
- Where it went
- US Nationwide distribution in the states of AL, CA, GA, NY.
- How much
- 115 kits
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug mol
Z-1786-2024 · Class III · reported 2024-05-15 · Ongoing
- Why it was recalled
- Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.
- Product
- Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
- Where it went
- US Nationwide distribution.
- How much
- 40 units
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum cov
Z-1759-2024 · Class II · reported 2024-05-15 · Ongoing
- Why it was recalled
- Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
- Product
- Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
- Where it went
- Domestic: Nationwide Distribution.
- How much
- 80,366 units (US: 242 units; OUS: 80,094 units)
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Z-1593-2024 · Class II · reported 2024-04-24 · Ongoing
- Why it was recalled
- Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
- Product
- Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
- Where it went
- US Nationwide distribution in the states of GA, MA, WV including PR.
- How much
- 8 units
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Z-1594-2024 · Class II · reported 2024-04-24 · Ongoing
- Why it was recalled
- Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
- Product
- Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
- Where it went
- US Nationwide distribution in the states of GA, MA, WV including PR.
- How much
- 6 units
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on aut
Z-1369-2024 · Class II · reported 2024-04-03 · Ongoing
- Why it was recalled
- Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
- Product
- Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
- Where it went
- US Nationwide distribution in the states of CA, IN.
- How much
- 666 units
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM a
Z-1328-2024 · Class II · reported 2024-03-27 · Ongoing
- Why it was recalled
- The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
- Product
- Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
- Where it went
- Domestic: CA, FL, IL, ME, NJ, OH, & OR.
- How much
- 1,764 units
RX Series Copper (Cu) Assay Ref. Number CU2340
Z-0992-2024 · Class II · reported 2024-02-14 · Ongoing
- Why it was recalled
- Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.
- Product
- RX Series Copper (Cu) Assay Ref. Number CU2340
- Where it went
- US Nationwide distribution in the states of SC and OK.
- How much
- 3,053 kits (2 US, 3,051 OUS)
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Z-0753-2024 · Class II · reported 2024-01-24 · Ongoing
- Why it was recalled
- Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
- Product
- Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
- Where it went
- US Nationwide including Puerto Rico.
- How much
- 108 kits
Calibration Serum Level 3 CAL2351
Z-0752-2024 · Class II · reported 2024-01-24 · Ongoing
- Why it was recalled
- CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
- Product
- Calibration Serum Level 3 CAL2351
- Where it went
- US Nationwide and Puerto Rico.
- How much
- 269 kits
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-S
Z-0751-2024 · Class II · reported 2024-01-24 · Ongoing
- Why it was recalled
- There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.
- Product
- Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
- Where it went
- US Nationwide distribution.
- How much
- N/A
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antib
Z-0624-2024 · Class III · reported 2024-01-10 · Ongoing
- Why it was recalled
- A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.
- Product
- SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number: SR10349
- Where it went
- NY, WV
- How much
- 1 unit
RANDOX Total Bilirubin.
Z-0501-2024 · Class II · reported 2023-12-13 · Ongoing
- Why it was recalled
- Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
- Product
- RANDOX Total Bilirubin.
- Where it went
- US Nationwide distribution in the states of AR, GA, NC, TN, & PR.
- How much
- 1644 units
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
Z-0201-2024 · Class II · reported 2023-11-08 · Ongoing
- Why it was recalled
- RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
- Product
- RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
- Where it went
- US Nationwide distribution including Puerto Rico
- How much
- O units
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
Z-0202-2024 · Class II · reported 2023-11-08 · Ongoing
- Why it was recalled
- RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
- Product
- RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
- Where it went
- US Nationwide distribution including Puerto Rico
- How much
- 13 units
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
Z-0200-2024 · Class II · reported 2023-11-08 · Ongoing
- Why it was recalled
- RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
- Product
- RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
- Where it went
- US Nationwide distribution including Puerto Rico
- How much
- 35 units
RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
Z-0198-2024 · Class II · reported 2023-11-08 · Ongoing
- Why it was recalled
- RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
- Product
- RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
- Where it went
- US Nationwide distribution including Puerto Rico
- How much
- 5 units
RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
Z-0199-2024 · Class II · reported 2023-11-08 · Ongoing
- Why it was recalled
- RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
- Product
- RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
- Where it went
- US Nationwide distribution including Puerto Rico
- How much
- 6 units
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Z-2609-2023 · Class II · reported 2023-09-27 · Ongoing
- Why it was recalled
- there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
- Product
- Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
- Where it went
- US States: GA, OH, OR, PA, TX, VA
- How much
- 66 kits
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Co
Z-2448-2023 · Class II · reported 2023-08-30 · Ongoing
- Why it was recalled
- As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.
- Product
- Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691
- Where it went
- CA, FL, IL, ME, MI, NC, OH, PA,NJ,
- How much
- 166 units
Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase,
Z-2446-2023 · Class II · reported 2023-08-30 · Ongoing
- Why it was recalled
- (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in the Instructions For Use (IFU). The target and ranges for Creatinine for the Roche Creatinine Plus method have been listed incorrectly. These failures cause a delay in patient results for the above mentioned analytes.
- Product
- Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems Catalog Number: UC5074
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AR, FL, GA, OH, VA including PR and WW distribution.
- How much
- 39 units
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR80
Z-2362-2023 · Class II · reported 2023-08-16 · Ongoing
- Why it was recalled
- Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.
- Product
- Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
- Where it went
- US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico.
- How much
- 37 US 194 PR
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accura
Z-2021-2023 · Class III · reported 2023-07-05 · Ongoing
- Why it was recalled
- Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
- Product
- Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
- Where it went
- CA, IL, VA, WA, WI including PR
- How much
- 1 kit
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor
Z-2022-2023 · Class III · reported 2023-07-05 · Ongoing
- Why it was recalled
- Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
- Product
- Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
- Where it went
- CA, IL, VA, WA, WI including PR
- How much
- 30 kits
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on
Z-0904-2023 · Class II · reported 2023-01-11 · Ongoing
- Why it was recalled
- Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
- Product
- Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
- Where it went
- US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
- How much
- 115 units
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistr
Z-0903-2023 · Class II · reported 2023-01-11 · Ongoing
- Why it was recalled
- Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
- Product
- Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
- Where it went
- US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
- How much
- 146 units US
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on c
Z-0905-2023 · Class II · reported 2023-01-11 · Ongoing
- Why it was recalled
- Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
- Product
- Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
- Where it went
- US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
- How much
- 49 units US
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM383
Z-0363-2023 · Class II · reported 2022-12-14 · Terminated
- Why it was recalled
- Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in running patient samples or erroneous elevated test results
- Product
- IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
- Where it went
- US Nationwide Distribution: CA, NC, NJ and WV,
- How much
- 20 kits US in total
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA38
Z-0362-2023 · Class II · reported 2022-12-14 · Terminated
- Why it was recalled
- Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in running patient samples or erroneous elevated test results
- Product
- IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
- Where it went
- US Nationwide Distribution: CA, NC, NJ and WV,
- How much
- 20 kits US in total
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, An
Z-1772-2022 · Class II · reported 2022-09-28 · Terminated
- Why it was recalled
- ***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Randox Serology I Positive Control will test negative (Non-Reactive) for Marker HBsAg resulting in delay in reporting patient results due to the positive control O36SR testing negative (Non-Reactive) for Marker HBsAg
- Product
- The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.
- Where it went
- US Nationwide distribution in the states of WV, NC.
- How much
- 2 units
Showing the 30 most recent of 79. The rest are searchable at the FDA enforcement report database.
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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