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Microbiologics Recalls
66 recalls on record · July 11, 2012 to December 31, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 9, 2022Medical DevicesFDA
Microbiologics Inc recalls Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
Hazard: Real-time shelf life testing failed at 24 months
March 9, 2022Medical DevicesFDA
Microbiologics Inc recalls Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Targ
Hazard: Real-time shelf life testing failed at 24 months
March 9, 2022Medical DevicesFDA
Microbiologics Inc recalls Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Le
Hazard: Real-time shelf life testing failed at 24 months
March 9, 2022Medical DevicesFDA
Microbiologics Inc recalls Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) inclu
Hazard: Real-time shelf life testing failed at 24 months
February 23, 2022Medical DevicesFDA
Microbiologics Inc recalls KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived fr
Hazard: Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism.
February 16, 2022Medical DevicesFDA
Microbiologics Inc recalls LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellet
Hazard: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
February 16, 2022Medical DevicesFDA
Microbiologics Inc recalls KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet o
Hazard: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
February 16, 2022Medical DevicesFDA
Microbiologics Inc recalls QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that
Hazard: Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
February 16, 2022Medical DevicesFDA
Microbiologics Inc recalls QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Di
Hazard: Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
February 16, 2022Medical DevicesFDA
Microbiologics Inc recalls QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Dia
Hazard: Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
February 16, 2022Medical DevicesFDA
Microbiologics Inc recalls LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Hazard: Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
February 16, 2022Medical DevicesFDA
Microbiologics Inc recalls KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from AT
Hazard: Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
February 16, 2022Medical DevicesFDA
Microbiologics Inc recalls QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK uni
Hazard: Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.
February 16, 2022Medical DevicesFDA
Microbiologics Inc recalls LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are
Hazard: Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.
February 16, 2022Medical DevicesFDA
Microbiologics Inc recalls KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pac
Hazard: Potential contamination with S. epidermidis E. coli and S. warneri.
February 16, 2022Medical DevicesFDA
Microbiologics Inc recalls KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Hazard: The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the KWIK-STIK" canister label and KWIK-STIK" device label.
February 9, 2022Medical DevicesFDA
Microbiologics Inc recalls KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus a
Hazard: The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have been 7/31/2022.
February 9, 2022Medical DevicesFDA
Microbiologics Inc recalls KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD cont
Hazard: Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
February 9, 2022Medical DevicesFDA
Microbiologics Inc recalls KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Hazard: Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
January 26, 2022Medical DevicesFDA
Microbiologics Inc recalls KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis de
Hazard: Contamination with S. epidermidis
September 29, 2021Medical DevicesFDA
Microbiologics Inc recalls SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evalu
Hazard: The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.
September 29, 2021Medical DevicesFDA
Microbiologics Inc recalls SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to eva
Hazard: The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
November 11, 2020Medical DevicesFDA
Microbiologics Inc recalls Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify
Hazard: Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.
November 4, 2020Medical DevicesFDA
Microbiologics Inc recalls Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab.
Hazard: QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
November 4, 2020Medical DevicesFDA
Microbiologics Inc recalls Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab.
Hazard: KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
November 4, 2020Medical DevicesFDA
Microbiologics Inc recalls Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab.
Hazard: KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
April 15, 2020Medical DevicesFDA
Microbiologics Inc recalls Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, Q
Hazard: KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead of T. dermatis.
April 15, 2020Medical DevicesFDA
Microbiologics Inc recalls KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
Hazard: KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead of T. dermatis.
February 12, 2020Medical DevicesFDA
Microbiologics Inc recalls Vaginal Verification Panel Ref 8208 Lot 8208-11
Hazard: Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no impact on patient test results as long as Gardnerella vaginalis was properly detected when using Pool 2 and/or users are strictly using this product for instrument verification/validation.
January 22, 2020Medical DevicesFDA
Microbiologics Inc recalls Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used
Hazard: The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate buffer.