Microbiologics Inc
Medical device manufacturer in Saint Cloud, MN.
18510(k) clearances
0PMA approvals
67recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K190086 | Cepheid Xpert Respiratory Control PanelPMN · Traditional | 10/07/2019SE |
| K191168 | Cepheid Xpert SA Nasal Complete Control PanelPMN · Traditional | 06/25/2019SE |
| K191172 | Cepheid Xpert MRSA NxG Control PanelPMN · Traditional | 06/20/2019SE |
| K190223 | Cepheid Xpert CT/NG Control PanelPMN · Traditional | 05/08/2019SE |
| K190463 | Cepheid Xpert C. difficile/Epi Control PanelPMN · Traditional | 04/19/2019SE |
| K182472 | Cepheid Xpert GBS LB Control PanelPMN · Traditional | 11/08/2018SE |
| K181683 | BD MAX CT/GC/TV 20-Day QC PanelPMN · Traditional | 08/28/2018SE |
| K181711 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC PanelPMN · Traditional | 08/15/2018SE |
| K970009 | Lyfo(Tm) Differential Disk-BacitracinJTO · Traditional | 02/06/1997SE |
| K954812 | Lyfo(Tm) Differiental Disk-PyrJTO · Traditional | 12/20/1995SE |
| K951889 | Lyfo(Tm) Differential DiskJTO · Traditional | 08/24/1995SE |
| K945489 | Lyfo(Tm) Differential DiskJSP · Traditional | 05/11/1995SE |
| K945488 | Lyfo(Tm) Differential DiskJSP · Traditional | 05/11/1995SE |
| K945487 | Lyfo(Tm) Differential DiskJSP · Traditional | 05/11/1995SE |
| K945883 | Lyfo(Tm) Differential Disk-Bile EsculinJTO · Traditional | 04/24/1995SE |
| K945882 | Lyfo(Tm) Differential Disk-BileJTO · Traditional | 04/24/1995SE |
| K945881 | Lyfo(Tm) Differential Disk-Sterile DiskJTO · Traditional | 04/24/1995SE |
| K945880 | Lyfo(Tm) Differential Disk-SpsJTO · Traditional | 04/24/1995SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0986-2026 Class II | LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number…Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from… | 12/02/2025Open, Classified |
| Z-0985-2026 Class II | KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog…Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from… | 12/02/2025Open, Classified |
| Z-0984-2026 Class II | KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog…Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from… | 12/02/2025Open, Classified |
| Z-0876-2026 Class II | KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from…Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. | 11/13/2025Open, Classified |
| Z-2195-2025 Class II | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894LKWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target… | 06/27/2025Open, Classified |
| Z-2194-2025 Class II | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF…KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target… | 06/27/2025Open, Classified |
| Z-2124-2025 Class II | KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805LAffected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This… | 06/17/2025Open, Classified |
| Z-1957-2025 Class II | KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella…Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing… | 05/27/2025Open, Classified |
| Z-1454-2025 Class II | Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial…The RSV target may give a late Ct value and could potentially not pass QC. | 02/20/2025Open, Classified |
| Z-1371-2025 Class II | Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet)…The A549 human cell target (human cells for sample adequacy control) may give a late Ct value. | 02/20/2025Open, Classified |
| Z-1164-2025 Class II | Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated…Internal quality control procedures were not followed correctly for the testing/release of three lots of… | 01/20/2025Open, Classified |
| Z-1163-2025 Class II | Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated…Internal quality control procedures were not followed correctly for the testing/release of three lots of… | 01/20/2025Open, Classified |
| Z-1483-2024 Class II | KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF…The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with… | 03/06/2024Open, Classified |
| Z-1075-2024 Class II | Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.The negative control was contaminated with one of the positive control pathogens (Norovirus). This would… | 01/08/2024Open, Classified |
| Z-0308-2024 Class II | LYFO-DISK, P. venetum, Catalog number 0794LA complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus… | 10/18/2023Open, Classified |
| Z-0307-2024 Class II | 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… | 10/18/2023Open, Classified |
| Z-2576-2023 Class III | KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testingOne lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis. | 08/14/2023Open, Classified |
| Z-1740-2022 Class III | Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole…Product not registered for use in the UK | 07/27/2022Terminated |
| Z-1125-2022 Class III | KWIK-STIK" plus: Clostridium perfringensLabeling error. | 05/06/2022Terminated |
| Z-0954-2022 Class II | Inactivated macrolide and quinolone-resistant Mycoplasma genitaliumQC process was not adequate for the specification range. | 03/24/2022Terminated |
| Z-0955-2022 Class II | Inactivated macrolide-resistant Mycoplasma genitaliumThe QC process was not adequate for the specification range. | 03/22/2022Terminated |
| Z-0844-2022 Class II | Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing:…Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months. | 03/03/2022Terminated |
| Z-0784-2022 Class II | Mycoplasma genitalium Control Panel (Inactivated Pellet)Distributed product did not undergo proper release testing. | 02/25/2022Terminated |
| Z-2487-2021 Class II | SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external…The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences. | 08/20/2021Terminated |
| Z-2486-2021 Class II | SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external…The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant… | 08/20/2021Terminated |
| Z-0544-2022 Class III | KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P.…Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10. | 02/24/2021Terminated |
| Z-0543-2022 Class III | KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per…Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7. | 02/24/2021Terminated |
| Z-0546-2022 Class III | KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component:…The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly… | 12/16/2020Terminated |
| Z-0511-2022 Class II | KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK…Contamination with S. epidermidis | 12/16/2020Terminated |
| Z-0581-2022 Class III | 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… | 10/08/2020Terminated |
| Z-0402-2021 Class II | Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended…Strain should be VIM-1 positive but is confirmed to be VIM-1 negative. | 10/08/2020Terminated |
| Z-0304-2021 Class II | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating…QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was… | 10/08/2020Terminated |
| Z-0303-2021 Class II | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating…KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1… | 10/08/2020Terminated |
| Z-0302-2021 Class II | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating…KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1… | 10/08/2020Terminated |
| Z-0584-2022 Class II | QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive…Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri. | 10/01/2020Terminated |
| Z-0583-2022 Class II | LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM).…Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri. | 10/01/2020Terminated |
| Z-0582-2022 Class II | KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as…Potential contamination with S. epidermidis E. coli and S. warneri. | 10/01/2020Terminated |
| Z-0589-2022 Class II | QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel…Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification… | 02/18/2020Terminated |
| Z-0588-2022 Class II | QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains…Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification… | 02/18/2020Terminated |
| Z-0587-2022 Class II | QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains…Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification… | 02/18/2020Terminated |
| Z-0586-2022 Class II | LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control…Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification… | 02/18/2020Terminated |
| Z-0585-2022 Class II | KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack…Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification… | 02/18/2020Terminated |
| Z-1691-2020 Class II | Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing…KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain… | 02/12/2020Terminated |
| Z-1690-2020 Class II | KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot…KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain… | 02/12/2020Terminated |
| Z-1096-2020 Class II | Vaginal Verification Panel Ref 8208 Lot 8208-11Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2… | 01/03/2020Terminated |
| Z-0812-2020 Class II | Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel…The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet)… | 12/16/2019Terminated |
| Z-1838-2019 Class III | Cepheid Xpert C. difficile/Epi Control PanelProduct is labeled with expiration date of 2021-10-31, should be 2021-03-31. | 05/16/2019Open, Classified |
| Z-1731-2019 Class II | Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233…Product with incorrect shelf life. | 04/09/2019Open, Classified |
| Z-1730-2019 Class II | Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product…Product with incorrect shelf life. | 04/09/2019Open, Classified |
| Z-0982-2019 Class II | Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic useCepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13… | 01/31/2019Terminated |
| Z-0701-2022 Class II | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and…Real-time shelf life testing failed at 24 months | 06/06/2017Terminated |
| Z-0700-2022 Class II | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria…Real-time shelf life testing failed at 24 months | 06/06/2017Terminated |
| Z-0699-2022 Class II | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory…Real-time shelf life testing failed at 24 months | 06/06/2017Terminated |
| Z-0698-2022 Class II | Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel.…Real-time shelf life testing failed at 24 months | 06/06/2017Terminated |
| Z-0697-2022 Class II | Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification…Real-time shelf life testing failed at 24 months | 06/06/2017Terminated |
| Z-0637-2022 Class III | LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit…Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | 03/02/2017Terminated |
| Z-0636-2022 Class III | KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit…Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | 03/02/2017Terminated |
| Z-0704-2022 Class II | QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1.…The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid… | 12/01/2015Terminated |
| Z-0703-2022 Class II | QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1.…The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid… | 12/01/2015Terminated |
| Z-0788-2022 Class III | LYFO DiskLYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog… | 07/17/2015Completed |
| Z-0714-2022 Class II | KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack)…This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A… | 10/06/2014Terminated |
| Z-0713-2022 Class II | LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus…This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A… | 10/06/2014Terminated |
| Z-0712-2022 Class II | KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack…This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A… | 10/06/2014Terminated |
| Z-0641-2022 Class III | KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack…Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating… | 03/25/2013Terminated |
| Z-1021-2013 Class II | Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium…Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL42-10 and… | 02/11/2013Terminated |
| Z-1936-2012 Class II | Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides…Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram negative… | 05/29/2012Terminated |
| Z-0456-2008 | MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp…Mislabeled: DuoPacks of Proteus vulgaris contained Listeria monocytogenes instead of the labeled Proteus… | 10/12/2007Terminated |