Microbiologics Inc
Complete recall history across all FDA and CPSC categories — 66 total recalls
Microbiologics Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (66)
FDA medical device enforcement actions by Microbiologics Inc. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 2, 2025 | LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalo... | Affected units may fail to recover the target microorganism Campylobacter jej... | Class II |
| Dec 2, 2025 | KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428,... | Affected units may fail to recover the target microorganism Campylobacter jej... | Class II |
| Dec 2, 2025 | KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428,... | Affected units may fail to recover the target microorganism Campylobacter jej... | Class II |
| Nov 13, 2025 | KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus der... | Some products packaged for lot 818-111-7 may have been packaged in pouches la... | Class II |
| Jun 27, 2025 | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L | KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failu... | Class II |
| Jun 27, 2025 | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pa... | KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failu... | Class II |
| Jun 17, 2025 | KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 080... | Affected products contain Staphylococcus epidermidis instead of the expected ... | Class II |
| May 27, 2025 | KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K... | Affected products were packaged with the incorrect KWIK STIK assembly resulti... | Class II |
| Feb 20, 2025 | Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory S... | The RSV target may give a late Ct value and could potentially not pass QC. | Class II |
| Feb 20, 2025 | Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet... | The A549 human cell target (human cells for sample adequacy control) may give... | Class II |
| Jan 20, 2025 | Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (In... | Internal quality control procedures were not followed correctly for the testi... | Class II |
| Jan 20, 2025 | Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactiv... | Internal quality control procedures were not followed correctly for the testi... | Class II |
| Mar 6, 2024 | KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b... | The positive control material (Rhizopus stolonifer) within the KWIK-STIK asse... | Class II |
| Jan 8, 2024 | Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. | The negative control was contaminated with one of the positive control pathog... | Class II |
| Oct 18, 2023 | LYFO-DISK, P. venetum, Catalog number 0794L | A complaint investigation showed that the bulk pellets (lot 794-142) were con... | Class II |
| Oct 18, 2023 | KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack) | A complaint investigation showed that the bulk pellets (lot 794-142) were con... | Class II |
| Aug 14, 2023 | KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing | One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 60... | Class III |
| Jul 27, 2022 | Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B... | Product not registered for use in the UK | Class III |
| May 6, 2022 | KWIK-STIK" plus: Clostridium perfringens | Labeling error. | Class III |
| Mar 24, 2022 | Inactivated macrolide and quinolone-resistant Mycoplasma genitalium | QC process was not adequate for the specification range. | Class II |
| Mar 22, 2022 | Inactivated macrolide-resistant Mycoplasma genitalium | The QC process was not adequate for the specification range. | Class II |
| Mar 3, 2022 | Pneumonia (33 Targets) Control Panel, unassayed quality control material, con... | Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be... | Class II |
| Feb 25, 2022 | Mycoplasma genitalium Control Panel (Inactivated Pellet) | Distributed product did not undergo proper release testing. | Class II |
| Aug 20, 2021 | SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an ext... | The product indicated is contaminated with a plasmid DNA that contains the ta... | Class II |
| Aug 20, 2021 | SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an e... | The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include... | Class II |
| Feb 24, 2021 | KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged... | Potential that products packaged for lot 726-57-10 were packaged in pouches l... | Class III |
| Feb 24, 2021 | KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0... | Potential of products packaged for lot 323-108-7 were packaged in pouches lab... | Class III |
| Dec 16, 2020 | KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO ... | Contamination with S. epidermidis | Class II |
| Dec 16, 2020 | KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affecte... | The expiration date on the label of one component (negative control 0243U) in... | Class III |
| Oct 8, 2020 | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o... | QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-... | Class II |
| Oct 8, 2020 | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o... | KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 0114... | Class II |
| Oct 8, 2020 | KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM) | The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is... | Class III |
| Oct 8, 2020 | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o... | KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 0114... | Class II |
| Oct 8, 2020 | Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage... | Strain should be VIM-1 positive but is confirmed to be VIM-1 negative. | Class II |
| Oct 1, 2020 | LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49... | Potential contamination with Escherichia coli, Staphylococcus epidermidis an... | Class II |
| Oct 1, 2020 | QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Co... | Potential contamination with Escherichia coli Staphylococcus epidermidis and ... | Class II |
| Oct 1, 2020 | KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packa... | Potential contamination with S. epidermidis E. coli and S. warneri. | Class II |
| Feb 18, 2020 | KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2... | Tests returning incorrect susceptible results. High Level Gentamicin Synergy... | Class II |
| Feb 18, 2020 | QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that ... | Tests returning incorrect susceptible results. High Level Gentamicin Synergy... | Class II |
| Feb 18, 2020 | LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic ... | Tests returning incorrect susceptible results. High Level Gentamicin Synergy... | Class II |
| Feb 18, 2020 | QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verificatio... | Tests returning incorrect susceptible results. High Level Gentamicin Synergy... | Class II |
| Feb 18, 2020 | QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that ... | Tests returning incorrect susceptible results. High Level Gentamicin Synergy... | Class II |
| Feb 12, 2020 | KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 077... | KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive... | Class II |
| Feb 12, 2020 | Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, conta... | KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive... | Class II |
| Jan 3, 2020 | Vaginal Verification Panel Ref 8208 Lot 8208-11 | Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant C... | Class II |
| Dec 16, 2019 | Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel ... | The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Cont... | Class II |
| May 16, 2019 | Cepheid Xpert C. difficile/Epi Control Panel | Product is labeled with expiration date of 2021-10-31, should be 2021-03-31. | Class III |
| Apr 9, 2019 | Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 7084535704... | Product with incorrect shelf life. | Class II |
| Apr 9, 2019 | Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226... | Product with incorrect shelf life. | Class II |
| Jan 31, 2019 | Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use | Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expira... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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