Skip to main content
All Recalls

Every Microbiologics Inc Recall

Sorted by most recent. Click any recall for full details.

45 recalls
High RiskFDA
Microbiologics Inc
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Medical Devices·86 affected·Dec 2, 2025
High RiskFDA
Microbiologics Inc
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Medical Devices·18 affected·Dec 2, 2025
High RiskFDA
Microbiologics Inc
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Medical Devices·1 affected·Dec 2, 2025
High RiskFDA
Microbiologics Inc
KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Medical Devices·5 affected·Nov 13, 2025
High RiskFDA
Microbiologics Inc
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
Medical Devices·32 affected·Jun 27, 2025
High RiskFDA
Microbiologics Inc
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, St...
Medical Devices·3 affected·May 27, 2025
High RiskFDA
Microbiologics Inc
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalo...
Diagnostic Devices·6 affected·Feb 20, 2025
High RiskFDA
Microbiologics Inc
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control mat...
Respiratory Devices·28 affected·Feb 20, 2025
High RiskFDA
Microbiologics Inc
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Diagnostic Devices·16 affected·Jan 20, 2025
High RiskFDA
Microbiologics Inc
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Diagnostic Devices·27 affected·Jan 20, 2025
High RiskFDA
Microbiologics Inc
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
Medical Devices·19 affected·Mar 6, 2024
High RiskFDA
Microbiologics Inc
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Medical Devices·580 affected·Jan 8, 2024
High RiskFDA
Microbiologics Inc
KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
Medical Devices·13 affected·Oct 18, 2023
RecallFDA
Microbiologics Inc
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2...
Medical Devices·2 affected·Jul 27, 2022
RecallFDA
Microbiologics Inc
KWIK-STIK" plus: Clostridium perfringens
Medical Devices·8 affected·May 6, 2022
High RiskFDA
Microbiologics Inc
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Medical Devices·1 affected·Mar 24, 2022
High RiskFDA
Microbiologics Inc
Inactivated macrolide-resistant Mycoplasma genitalium
Medical Devices·2 affected·Mar 22, 2022
High RiskFDA
Microbiologics Inc
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria...
Diagnostic Devices·13 affected·Mar 3, 2022
High RiskFDA
Microbiologics Inc
Mycoplasma genitalium Control Panel (Inactivated Pellet)
Medical Devices·80 affected·Feb 25, 2022
High RiskFDA
Microbiologics Inc
SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the perform...
Medical Devices·218 affected·Aug 20, 2021
RecallFDA
Microbiologics Inc
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Medical Devices·47 affected·Feb 24, 2021
RecallFDA
Microbiologics Inc
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Medical Devices·65 affected·Feb 24, 2021
RecallFDA
Microbiologics Inc
KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derive...
Medical Devices·0 affected·Dec 16, 2020
High RiskFDA
Microbiologics Inc
KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 3...
Medical Devices·59 affected·Dec 16, 2020
High RiskFDA
Microbiologics Inc
Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance ...
Diagnostic Devices·46 affected·Oct 8, 2020
High RiskFDA
Microbiologics Inc
Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is s...
Medical Devices·1 affected·Oct 8, 2020
RecallFDA
Microbiologics Inc
KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Medical Devices·187 affected·Oct 8, 2020
High RiskFDA
Microbiologics Inc
KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-S...
Medical Devices·271 affected·Oct 1, 2020
High RiskFDA
Microbiologics Inc
QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control m...
Diagnostic Devices·10 affected·Feb 18, 2020
High RiskFDA
Microbiologics Inc
QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog...
Diagnostic Devices·3 affected·Feb 18, 2020
High RiskFDA
Microbiologics Inc
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Diagnostic Devices·183 affected·Feb 18, 2020
High RiskFDA
Microbiologics Inc
Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845...
Medical Devices·49 affected·Feb 12, 2020
High RiskFDA
Microbiologics Inc
Vaginal Verification Panel Ref 8208 Lot 8208-11
Medical Devices·9 affected·Jan 3, 2020
High RiskFDA
Microbiologics Inc
Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems t...
Diagnostic Devices·810 affected·Dec 16, 2019
High RiskFDA
Microbiologics Inc
Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent AC...
Medical Devices·249 affected·Apr 9, 2019
High RiskFDA
Microbiologics Inc
Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets ea...
Medical Devices·8 affected·Jun 6, 2017
High RiskFDA
Microbiologics Inc
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
Medical Devices·1 affected·Jun 6, 2017
High RiskFDA
Microbiologics Inc
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are ...
Respiratory Devices·1 affected·Jun 6, 2017
RecallFDA
Microbiologics Inc
LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single mic...
Medical Devices·1 affected·Mar 2, 2017
High RiskFDA
Microbiologics Inc
QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) ...
Medical Devices·8 affected·Dec 1, 2015
High RiskFDA
Microbiologics Inc
QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb)...
Medical Devices·541 affected·Dec 1, 2015
RecallFDA
Microbiologics Inc
LYFO Disk
Medical Devices·3 affected·Jul 17, 2015
High RiskFDA
Microbiologics Inc
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
Medical Devices·150 affected·Oct 6, 2014
High RiskFDA
Microbiologics Inc
KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KW...
Medical Devices·1,873 affected·Oct 6, 2014
RecallFDA
Microbiologics Inc
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
Medical Devices·10 affected·Mar 25, 2013