Microbiologics Inc: 66 FDA recall reports
Every medical device recall the FDA has published for Microbiologics Inc. The fault, and how the agency graded it.
66Reports
0Class I
20Ongoing
2025-12-31Most 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.
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Z-0984-2026 · Class II · reported 2025-12-31 · Ongoing
- Why it was recalled
- Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
- Product
- KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
- Where it went
- Worldwide - US Nationwide.
- How much
- 86 units (127 additional units 12/22/25)
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Z-0985-2026 · Class II · reported 2025-12-31 · Ongoing
- Why it was recalled
- Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
- Product
- KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
- Where it went
- Worldwide - US Nationwide.
- How much
- 18 units (9 additional units 12/22/25)
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Z-0986-2026 · Class II · reported 2025-12-31 · Ongoing
- Why it was recalled
- Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
- Product
- LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
- Where it went
- Worldwide - US Nationwide.
- How much
- 1 unit (16 additional units added 12/22/25)
KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Num
Z-0876-2026 · Class II · reported 2025-12-10 · Ongoing
- Why it was recalled
- Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
- Product
- KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
- Where it went
- International distribution to the countries of UAE, China, Singapore, Kazakhstan,
- How much
- 5 units
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
Z-2194-2025 · Class II · reported 2025-08-06 · Ongoing
- Why it was recalled
- KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
- Product
- LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
- Where it went
- Worldwide distribution - US Nationwide and the countries of France, Colombia, Philippines, Peru, Turkey, India, Finland, Trinidad and Tobago, Poland, Viet Nam, Brazil, Japan, Malaysia, Costa Rica.
- How much
- 32 units
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
Z-2195-2025 · Class II · reported 2025-08-06 · Ongoing
- Why it was recalled
- KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
- Product
- LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
- Where it went
- Worldwide distribution - US Nationwide and the countries of France, Colombia, Philippines, Peru, Turkey, India, Finland, Trinidad and Tobago, Poland, Viet Nam, Brazil, Japan, Malaysia, Costa Rica.
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Z-2124-2025 · Class II · reported 2025-07-23 · Ongoing
- Why it was recalled
- Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.
- Product
- KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
- Where it went
- US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
- How much
- 21 total
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived fro
Z-1957-2025 · Class II · reported 2025-06-18 · Ongoing
- Why it was recalled
- Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.
- Product
- KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
- Where it went
- US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.
- How much
- 3 total
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, un
Z-1454-2025 · Class II · reported 2025-04-02 · Ongoing
- Why it was recalled
- The RSV target may give a late Ct value and could potentially not pass QC.
- Product
- Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
- Where it went
- Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.
- How much
- 28 units
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quali
Z-1371-2025 · Class II · reported 2025-03-26 · Ongoing
- Why it was recalled
- The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
- Product
- Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
- Where it went
- US Nationwide distribution in the states of TX. UK.
- How much
- 6 units
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro
Z-1163-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
- Product
- Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
- Where it went
- Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
- How much
- 16 units
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-v
Z-1164-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
- Product
- Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
- Where it went
- Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
- How much
- 27 units
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit
Z-1483-2024 · Class II · reported 2024-04-17 · Ongoing
- Why it was recalled
- The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control material.
- Product
- KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, MI, KY, MO, NM, TN, PR, and the countries of France, Columbia, Kazakhstan, Peru, Puerto Rico, South Africa.
- How much
- 19 units
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Z-1075-2024 · Class II · reported 2024-02-21 · Ongoing
- Why it was recalled
- The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for Norovirus when running the negative control.
- Product
- Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
- Where it went
- US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NE, NH, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV, and WY. There was government distribution and no military distribution. Foreign distribution was made to France.
- How much
- 580 packages
KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
Z-0307-2024 · Class II · reported 2023-11-22 · Ongoing
- Why it was recalled
- A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
- Product
- KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
- Where it went
- Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.
- How much
- 13 units
LYFO-DISK, P. venetum, Catalog number 0794L
Z-0308-2024 · Class II · reported 2023-11-22 · Ongoing
- Why it was recalled
- A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
- Product
- LYFO-DISK, P. venetum, Catalog number 0794L
- Where it went
- Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.
- How much
- 3 units
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Z-2576-2023 · Class III · reported 2023-09-20 · Ongoing
- Why it was recalled
- One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
- Product
- KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
- Where it went
- US Nationwide distribution in the states of MN, PA, TN, TX.
- How much
- 4 units
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N;
Z-1740-2022 · Class III · reported 2022-09-21 · Terminated
- Why it was recalled
- Product not registered for use in the UK
- Product
- Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
- Where it went
- International distribution to the country of United Kingdom.
- How much
- 2
KWIK-STIK" plus: Clostridium perfringens
Z-1125-2022 · Class III · reported 2022-06-01 · Terminated
- Why it was recalled
- Labeling error.
- Product
- KWIK-STIK" plus: Clostridium perfringens
- Where it went
- Distributed US Nationwide to IA, TN and internationally to Mexico, Colombia, France, South Africa, United Kingdom.
- How much
- 8 units
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Z-0954-2022 · Class II · reported 2022-04-27 · Terminated
- Why it was recalled
- QC process was not adequate for the specification range.
- Product
- Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
- Where it went
- US Nationwide distribution in the state of TX.
- How much
- 1 ea
Inactivated macrolide-resistant Mycoplasma genitalium
Z-0955-2022 · Class II · reported 2022-04-27 · Terminated
- Why it was recalled
- The QC process was not adequate for the specification range.
- Product
- Inactivated macrolide-resistant Mycoplasma genitalium
- Where it went
- US Nationwide distribution in the states of NV and VT.
- How much
- 2 ea
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 -
Z-0844-2022 · Class II · reported 2022-04-06 · Terminated
- Why it was recalled
- Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
- Product
- Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
- Where it went
- US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin
- How much
- 13 units
LYFO Disk
Z-0788-2022 · Class III · reported 2022-03-23 · Completed
- Why it was recalled
- LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.
- Product
- LYFO Disk
- Where it went
- Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.
- How much
- 3 units
Mycoplasma genitalium Control Panel (Inactivated Pellet)
Z-0784-2022 · Class II · reported 2022-03-23 · Terminated
- Why it was recalled
- Distributed product did not undergo proper release testing.
- Product
- Mycoplasma genitalium Control Panel (Inactivated Pellet)
- Where it went
- Distribution in US: AZ, CT, DC, FL, IL, IN, KS, KY, MA, MD, NC, NH, NJ, NY, PA, TX, UT, WA OUS distribution to Belgium, Finland, France, Germany, Ireland, Sweden, United Kingdom, and Vietnam
- How much
- 80 units
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis d
Z-0714-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
- Product
- KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
- Where it went
- Worldwide distribution - US Nationwide and the countries of Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia/Hrvatska, Ecuador, Finland, France, Germany, Guam, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Macedonia, Malaysia, Netherlands, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, United Arab Emirates, and Vietnam.
- How much
- 150 units
Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pel
Z-0697-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- Real-time shelf life testing failed at 24 months
- Product
- Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derived from CDC 2010C-3114 (STEC), 4. C. jejuni derived from NCTC 11322, 5. P. shigelloides derived from NCTC 10363, 6. Y. enterocolitica derived from NCTC 11174, 7. E. coli derived from NCTC 11602 (ETEC), 8. V. parahaemolyticus derived from NCTC 13209
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.
- How much
- 8 units
QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcu
Z-0704-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Streptococcus (GBS) in some cases. This causes a failure when used as a quality control for the Cepheid Xpert GBS and Cepheid Smart GBS systems. The failure of the quality control test causes a disruption for the testing laboratory which may result in repeated testing or the need for alternative test methods. This recall is applicable to the 8164 and 8165 sets only.
- Product
- QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 4. Negative Control 0243 Lactobacillus acidophilus derived from ATCC 4356
- Where it went
- US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, NC, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI, WV, WY.
- How much
- 8 units
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
Z-0700-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- Real-time shelf life testing failed at 24 months
- Product
- Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.
- How much
- 1
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long
Z-0699-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- Real-time shelf life testing failed at 24 months
- Product
- Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use foil pouch. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.
- How much
- 1 unit
KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis deriv
Z-0712-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
- Product
- KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
- Where it went
- Worldwide distribution - US Nationwide and the countries of Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia/Hrvatska, Ecuador, Finland, France, Germany, Guam, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Macedonia, Malaysia, Netherlands, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, United Arab Emirates, and Vietnam.
- How much
- 1,873 units
Showing the 30 most recent of 66. 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.
← All device recalls