PlainRecalls

Microbiologics Inc

Compiled from official public sources by the editorial team.

66 recalls on record · Latest: Dec 31, 2025

Microbiologics Inc Recall Insight

Microbiologics Inc appears on 66 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.065% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 31, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 39 moderate, and 11 lower-severity recalls. Affected-unit counts are disclosed on 49 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Jan 26, 2022 to Dec 31, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Dec 31, 2025

KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P

FDA Devices Moderate Dec 31, 2025

KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K

FDA Devices Moderate Dec 31, 2025

LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L

FDA Devices Moderate Dec 10, 2025

KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K

FDA Devices Moderate Aug 6, 2025

LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)

FDA Devices Moderate Aug 6, 2025

LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L

FDA Devices Moderate Jul 23, 2025

KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L

FDA Devices Moderate Jun 18, 2025

KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus…

FDA Devices Moderate Apr 2, 2025

Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catal…

FDA Devices Moderate Mar 26, 2025

Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0…

FDA Devices Moderate Feb 19, 2025

Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test

FDA Devices Moderate Feb 19, 2025

Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test

FDA Devices Moderate Apr 17, 2024

KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media

FDA Devices Moderate Feb 21, 2024

Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.

FDA Devices Moderate Nov 22, 2023

KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)

FDA Devices Moderate Nov 22, 2023

LYFO-DISK, P. venetum, Catalog number 0794L

FDA Devices Low Sep 20, 2023

KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing

FDA Devices Low Sep 21, 2022

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 Who…

FDA Devices Low Jun 1, 2022

KWIK-STIK" plus: Clostridium perfringens

FDA Devices Moderate Apr 27, 2022

Inactivated macrolide and quinolone-resistant Mycoplasma genitalium

FDA Devices Moderate Apr 27, 2022

Inactivated macrolide-resistant Mycoplasma genitalium

FDA Devices Moderate Apr 6, 2022

Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive C…

FDA Devices Low Mar 23, 2022

LYFO Disk

FDA Devices Moderate Mar 23, 2022

Mycoplasma genitalium Control Panel (Inactivated Pellet)

FDA Devices Moderate Mar 9, 2022

KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299

FDA Devices Moderate Mar 9, 2022

Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised…

FDA Devices Moderate Mar 9, 2022

QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from…

FDA Devices Moderate Mar 9, 2022

Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.

FDA Devices Moderate Mar 9, 2022

Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized …

FDA Devices Moderate Mar 9, 2022

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-pa…

FDA Devices Moderate Mar 9, 2022

QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived fro…

FDA Devices Moderate Mar 9, 2022

Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.

FDA Devices Moderate Mar 9, 2022

LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299

FDA Devices Moderate Mar 9, 2022

Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus

FDA Devices Low Feb 23, 2022

KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)

FDA Devices Low Feb 16, 2022

LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism s…

FDA Devices Moderate Feb 16, 2022

QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms

FDA Devices Moderate Feb 16, 2022

KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pa…

FDA Devices Low Feb 16, 2022

KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)

FDA Devices Moderate Feb 16, 2022

QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959…

FDA Devices Moderate Feb 16, 2022

LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms

FDA Devices Moderate Feb 16, 2022

QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized micr…

FDA Devices Low Feb 16, 2022

KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism stra…

FDA Devices Moderate Feb 16, 2022

LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable vial…

FDA Devices Moderate Feb 16, 2022

QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganis…

FDA Devices Moderate Feb 16, 2022

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-pa…

FDA Devices Low Feb 9, 2022

KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.

FDA Devices Low Feb 9, 2022

KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(…

FDA Devices Low Feb 9, 2022

KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.

FDA Devices Moderate Jan 26, 2022

KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.