Microbiologics recalls
33 official recalls and safety alerts involving Microbiologics since 2022-01, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Microbiologics or the relevant agency.
- 2025-12-31
USMicrobiologics Inc recalls KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
- 2025-12-10
- US
Microbiologics Inc recalls KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
FDA · DeviceMicrobiologics IncInternational distribution to the countries of UAE, China, Singapore,…Official notice → - 2025-08-06
- US
Microbiologics Inc recalls LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
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.
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide and the countries of France, Colombia,…Official notice → - 2025-07-23
- US
Microbiologics Inc recalls KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
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.
FDA · DeviceMicrobiologics IncUS distribution to states of: Utah and Ohio; and OUS (International) to…Official notice → - 2025-06-18
- US
Microbiologics Inc recalls KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K,…
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…
FDA · DeviceMicrobiologics IncUS Nationwide distribution in the states of California and Pennsylvania and…Official notice → - 2025-04-02
- US
Microbiologics Inc recalls Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control…
The RSV target may give a late Ct value and could potentially not pass QC.
FDA · DeviceMicrobiologics IncWorldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and…Official notice → - 2025-03-26
- US
Microbiologics Inc recalls Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog…
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
- 2025-02-19
- US
Microbiologics Inc recalls Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
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…
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide and the countries of Netherlands,…Official notice → - 2024-04-17
- US
Microbiologics Inc recalls KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
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…
FDA · DeviceMicrobiologics IncWorldwide - US Nationwide distribution in the states of CA, MI, KY, MO, NM,…Official notice → - 2024-02-21
- US
Microbiologics Inc recalls Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
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.
FDA · DeviceMicrobiologics IncUS Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA,…Official notice → - 2023-11-22
- US
Microbiologics Inc recalls 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 contaminated with Aspergillus flavus.
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide and the countries of Italy, France,…Official notice → - 2023-09-20
- US
Microbiologics Inc recalls 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, 6018P Parabacteroides distasonis.
FDA · DeviceMicrobiologics IncUS Nationwide distribution in the states of MN, PA, TN, TX.Official notice → - 2022-09-21
- US
Microbiologics Inc recalls Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2…
Product not registered for use in the UK
FDA · DeviceMicrobiologics IncInternational distribution to the country of United Kingdom.Official notice → - 2022-06-01
- US
Microbiologics Inc recalls KWIK-STIK" plus: Clostridium perfringens
Labeling error.
FDA · DeviceMicrobiologics IncDistributed US Nationwide to IA, TN and internationally to Mexico, Colombia,…Official notice → - 2022-04-27
- US
Microbiologics Inc recalls Inactivated macrolide-resistant Mycoplasma genitalium
The QC process was not adequate for the specification range.
FDA · DeviceMicrobiologics IncUS Nationwide distribution in the states of NV and VT.Official notice → - US
Microbiologics Inc recalls Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
QC process was not adequate for the specification range.
- 2022-04-06
- US
Microbiologics Inc recalls Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria…
Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
FDA · DeviceMicrobiologics IncUS distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania,…Official notice → - 2022-03-23
- US
Microbiologics Inc recalls LYFO Disk
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…
FDA · DeviceMicrobiologics IncDistribution is nationwide with three consignees located in Colorado, Georgia,…Official notice → - US
Microbiologics Inc recalls Mycoplasma genitalium Control Panel (Inactivated Pellet)
Distributed product did not undergo proper release testing.
FDA · DeviceMicrobiologics IncDistribution in US: AZ, CT, DC, FL, IL, IN, KS, KY, MA, MD, NC, NH, NJ, NY,…Official notice → - 2022-03-09
- US
Microbiologics Inc recalls KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
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.
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Microbiologics Inc recalls QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb)…
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…
FDA · DeviceMicrobiologics IncUS Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IA, IL,…Official notice → - US
Microbiologics Inc recalls Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets…
Real-time shelf life testing failed at 24 months
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide distribution in the states of AK, CA,…Official notice → - 2022-02-23
- US
Microbiologics Inc recalls KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
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…
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide and the countries of Canada, South…Official notice → - 2022-02-16
- US
Microbiologics Inc recalls LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single…
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
FDA · DeviceMicrobiologics IncInternational distribution in the countries of Canada and Germany.Official notice → - US
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 Diagnostic Control…
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…
FDA · DeviceMicrobiologics IncWorldwide Distribution. US nationwide including Puerto Rico and Guam,…Official notice → - US
Microbiologics Inc recalls 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…
Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide distribution in the states of AR, AZ,…Official notice → - US
Microbiologics Inc recalls LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a…
Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide distribution in the states of AR, AZ,…Official notice → - US
Microbiologics Inc recalls 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…
Potential contamination with S. epidermidis E. coli and S. warneri.
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide distribution in the states of AR, AZ,…Official notice → - US
Microbiologics Inc recalls 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 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…
FDA · DeviceMicrobiologics IncUS distribution to . International distribution to Austria, Botswana, Brazil,…Official notice → - 2022-02-09
- US
Microbiologics Inc recalls KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from…
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…
FDA · DeviceMicrobiologics IncUS Nationwide distribution in the states of AL, CA, CO, IL, MD, MO, MS, NM,…Official notice → - US
Microbiologics Inc recalls KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
FDA · DeviceMicrobiologics IncUS distribution to CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN. International…Official notice → - US
Microbiologics Inc recalls KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
FDA · DeviceMicrobiologics IncWorldwide distribution - US distribution in the states of GA, MS, MT, NC, NM,…Official notice → - 2022-01-26
- US
Microbiologics Inc recalls KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC…
Contamination with S. epidermidis
FDA · DeviceMicrobiologics IncDistribution was made to CA, IA, IL, LA, MA, MI, NY, PA, SD, TN, VA, WI, and…Official notice →