Microbiologics recalls
Microbiologics appears in 66 official U.S. recall notices indexed by RecallRadar, most recently on 2025-12-31.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 66 |
|---|---|
| Published | 2012-07-11 to 2025-12-31 |
| By agency | FDA Device (66) |
| By classification | Class II (54), Class III (12) |
| By status | terminated (45), ongoing (20), completed (1) |
| Distribution named in notices | AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, US, UT, VA, WA, WI, WV |
Recalls
- KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
FDA Device · Class II · 2025-12-31 · Microbiologics
Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. - LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
FDA Device · Class II · 2025-12-31 · Microbiologics
Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. - KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
FDA Device · Class II · 2025-12-31 · Microbiologics
Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. - KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
FDA Device · Class II · 2025-12-10 · Microbiologics
Reason: Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. - LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
FDA Device · Class II · 2025-08-06 · Microbiologics
Reason: 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. - LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
FDA Device · Class II · 2025-08-06 · Microbiologics
Reason: 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. - KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
FDA Device · Class II · 2025-07-23 · Microbiologics
Reason: 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. - KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960
FDA Device · Class II · 2025-06-18 · Microbiologics
Reason: 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… - Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control mater…
FDA Device · Class II · 2025-04-02 · Microbiologics
Reason: The RSV target may give a late Ct value and could potentially not pass QC. - Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog…
FDA Device · Class II · 2025-03-26 · Microbiologics
Reason: The A549 human cell target (human cells for sample adequacy control) may give a late Ct value. - Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234
FDA Device · Class II · 2025-02-19 · Microbiologics
Reason: 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… - Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235
FDA Device · Class II · 2025-02-19 · Microbiologics
Reason: 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… - KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
FDA Device · Class II · 2024-04-17 · Microbiologics
Reason: 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 usin… - Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184
FDA Device · Class II · 2024-02-21 · Microbiologics
Reason: 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. - KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
FDA Device · Class II · 2023-11-22 · Microbiologics
Reason: A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus. - LYFO-DISK, P. venetum, Catalog number 0794L
FDA Device · Class II · 2023-11-22 · Microbiologics
Reason: A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus. - KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P
FDA Device · Class III · 2023-09-20 · Microbiologics
Reason: One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis. - Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N
FDA Device · Class III · 2022-09-21 · Microbiologics
Reason: Product not registered for use in the UK - KWIK-STIK" plus: Clostridium perfringens
FDA Device · Class III · 2022-06-01 · Microbiologics
Reason: Labeling error. - Inactivated macrolide-resistant Mycoplasma genitalium
FDA Device · Class II · 2022-04-27 · Microbiologics
Reason: The QC process was not adequate for the specification range. - Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
FDA Device · Class II · 2022-04-27 · Microbiologics
Reason: QC process was not adequate for the specification range. - Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Posit…
FDA Device · Class II · 2022-04-06 · Microbiologics
Reason: Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months. - LYFO Disk
FDA Device · Class III · 2022-03-23 · Microbiologics
Reason: 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 qua… - Mycoplasma genitalium Control Panel (Inactivated Pellet)
FDA Device · Class II · 2022-03-23 · Microbiologics
Reason: Distributed product did not undergo proper release testing. - QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture)
FDA Device · Class II · 2022-03-09 · Microbiologics
Reason: 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… - Microbiologics QC Sets and Panels
FDA Device · Class II · 2022-03-09 · Microbiologics
Reason: Real-time shelf life testing failed at 24 months - Helix Elite" Molecular Standards: Inactivated Standard
FDA Device · Class II · 2022-03-09 · Microbiologics
Reason: Real-time shelf life testing failed at 24 months - LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
FDA Device · Class II · 2022-03-09 · Microbiologics
Reason: 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. - 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…
FDA Device · Class II · 2022-03-09 · Microbiologics
Reason: 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. - Helix Elite" Molecular Standards: Inactivated Standard
FDA Device · Class II · 2022-03-09 · Microbiologics
Reason: Real-time shelf life testing failed at 24 months - KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
FDA Device · Class II · 2022-03-09 · Microbiologics
Reason: 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. - Microbiologics QC Sets and Panels: Helix Elite
FDA Device · Class II · 2022-03-09 · Microbiologics
Reason: Real-time shelf life testing failed at 24 months - Helix Elite" Molecular Standards: Inactivated Standard
FDA Device · Class II · 2022-03-09 · Microbiologics
Reason: Real-time shelf life testing failed at 24 months - QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture)
FDA Device · Class II · 2022-03-09 · Microbiologics
Reason: 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… - 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 Device · Class III · 2022-02-23 · Microbiologics
Reason: 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 t… - LYSO Disk(TM) labeled as containing Actinomyces odontolyticus
FDA Device · Class III · 2022-02-16 · Microbiologics
Reason: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. - LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
FDA Device · Class II · 2022-02-16 · Microbiologics
Reason: 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 fo… - 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…
FDA Device · Class II · 2022-02-16 · Microbiologics
Reason: 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 fo… - QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set
FDA Device · Class II · 2022-02-16 · Microbiologics
Reason: 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 fo… - KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack
FDA Device · Class II · 2022-02-16 · Microbiologics
Reason: Potential contamination with S. epidermidis E. coli and S. warneri. - QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set
FDA Device · Class II · 2022-02-16 · Microbiologics
Reason: 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 fo… - QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture)
FDA Device · Class II · 2022-02-16 · Microbiologics
Reason: 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 fo… - KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
FDA Device · Class III · 2022-02-16 · Microbiologics
Reason: 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-STI… - KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus
FDA Device · Class III · 2022-02-16 · Microbiologics
Reason: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. - QC Sets and Panels: KWIK-STIK" 2 Pack
FDA Device · Class II · 2022-02-16 · Microbiologics
Reason: Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri. - LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable…
FDA Device · Class II · 2022-02-16 · Microbiologics
Reason: Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri. - KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from…
FDA Device · Class III · 2022-02-09 · Microbiologics
Reason: 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… - KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack
FDA Device · Class III · 2022-02-09 · Microbiologics
Reason: Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10. - KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack
FDA Device · Class III · 2022-02-09 · Microbiologics
Reason: Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7. - KWIK-STIK 2 Pack, Catalog #0894P
FDA Device · Class II · 2022-01-26 · Microbiologics
Reason: Contamination with S. epidermidis