Microbiologics, Inc.
Lexington, KY, US
MICROBIOLOGICS, INC. appears in FDA device records in Lexington, KY. FDA records list 22 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 71 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Microbiologics, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Gibson Bioscienceenforcement report, recall
- Gibson Laboratories, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 22 510(k) clearances for Microbiologics, Inc. between 1990 and 2019. The busiest year on record is 1995, with 10. The most recent is 2019, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 2 |
| 1995 | 10 |
| 1996 | 1 |
| 1997 | 1 |
| 2018 | 3 |
| 2019 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K190086 | Cepheid Xpert Respiratory Control Panel | PMN | Substantially Equivalent | |
| K191168 | Cepheid Xpert SA Nasal Complete Control Panel | PMN | Substantially Equivalent | |
| K191172 | Cepheid Xpert MRSA NxG Control Panel | PMN | Substantially Equivalent | |
| K190223 | Cepheid Xpert CT/NG Control Panel | PMN | Substantially Equivalent | |
| K190463 | Cepheid Xpert C. difficile/Epi Control Panel | PMN | Substantially Equivalent | |
| K182472 | Cepheid Xpert GBS LB Control Panel | PMN | Substantially Equivalent | |
| K181683 | BD MAX CT/GC/TV 20-Day QC Panel | PMN | Substantially Equivalent | |
| K181711 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel | PMN | Substantially Equivalent | |
| K970009 | LYFO(TM) DIFFERENTIAL DISK-BACITRACIN | JTO | Substantially Equivalent | |
| K955826 | GIBSON ID-M. CAT. | JTO | Substantially Equivalent | |
| K954812 | LYFO(TM) DIFFERIENTAL DISK-PYR | JTO | Substantially Equivalent | |
| K953247 | GIBSON ID A.E. TEST | JTO | Substantially Equivalent | |
| K951889 | LYFO(TM) DIFFERENTIAL DISK | JTO | Substantially Equivalent | |
| K945489 | LYFO(TM) DIFFERENTIAL DISK | JSP | Substantially Equivalent | |
| K945488 | LYFO(TM) DIFFERENTIAL DISK | JSP | Substantially Equivalent | |
| K945487 | LYFO(TM) DIFFERENTIAL DISK | JSP | Substantially Equivalent | |
| K945883 | LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN | JTO | Substantially Equivalent | |
| K945882 | LYFO(TM) DIFFERENTIAL DISK-BILE | JTO | Substantially Equivalent | |
| K945881 | LYFO(TM) DIFFERENTIAL DISK-STERILE DISK | JTO | Substantially Equivalent | |
| K945880 | LYFO(TM) DIFFERENTIAL DISK-SPS | JTO | Substantially Equivalent | |
| K905120 | SAF FIXATIVE | LIO | Substantially Equivalent | |
| K904773 | P AND T MEDIUM | JTW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2150138 | 2150138 | MICROBIOLOGICS, INC. | 200 Cooper Avenue North, Saint Cloud, MN 56303 US | 2026 | |
| 1050138 | 1050138 | Microbiologics, Inc. | 1040 Manchester St, LEXINGTON, KY 40508 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- LIBDevice, General Purpose, Microbiology, Diagnostic
- LIODevice, Specimen Collection
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- PPMGeneral Purpose Reagent
- JSPKit, Anaerobic Identification
- JTRKit, Quality Control For Culture Media
- OHQMulti-Analyte Controls Unassayed
- LJGQuality Control Slides
- JTSStains, Microbiologic
- JTWSystem, Transport, Aerobic
Recall records
Showing 25 of 71| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0986-2026 | LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. | Class II | Open, Classified | |
| Z-0985-2026 | KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. | Class II | Open, Classified | |
| Z-0984-2026 | 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. | Class II | Open, Classified | |
| Z-0876-2026 | 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. | Class II | Open, Classified | |
| Z-2195-2025 | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L | 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. | Class II | Open, Classified | |
| Z-2194-2025 | 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. | Class II | Open, Classified | |
| Z-2124-2025 | 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. | Class II | Open, Classified | |
| Z-1957-2025 | KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC 17960; 0621K, Staphylococcus aureus derived from NCTC 12493 | 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 delayed diagnosis. | Class II | Open, Classified | |
| Z-1371-2025 | Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N | The A549 human cell target (human cells for sample adequacy control) may give a late Ct value. | Class II | Open, Classified | |
| Z-1454-2025 | Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N | The RSV target may give a late Ct value and could potentially not pass QC. | Class II | Open, Classified | |
| Z-1164-2025 | Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; 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 of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays. | Class II | Open, Classified | |
| Z-1163-2025 | 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 of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays. | Class II | Open, Classified | |
| Z-1483-2024 | 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 using the control material. | Class II | Open, Classified | |
| Z-1075-2024 | 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. | Class II | Open, Classified | |
| Z-0308-2024 | LYFO-DISK, P. venetum, Catalog number 0794L | A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus. | Class II | Open, Classified | |
| Z-0307-2024 | 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. | Class II | Open, Classified | |
| Z-2576-2023 | 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. | Class III | Open, Classified | |
| Z-1740-2022 | Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N | Product not registered for use in the UK | Class III | Terminated | |
| Z-1125-2022 | KWIK-STIK" plus: Clostridium perfringens | Labeling error. | Class III | Terminated | |
| Z-0954-2022 | Inactivated macrolide and quinolone-resistant Mycoplasma genitalium | QC process was not adequate for the specification range. | Class II | Terminated | |
| Z-0955-2022 | Inactivated macrolide-resistant Mycoplasma genitalium | The QC process was not adequate for the specification range. | Class II | Terminated | |
| Z-0844-2022 | Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria | Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months. | Class II | Terminated | |
| Z-0784-2022 | Mycoplasma genitalium Control Panel (Inactivated Pellet) | Distributed product did not undergo proper release testing. | Class II | Terminated | |
| Z-2487-2021 | SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. | The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences. | Class II | Terminated | |
| Z-2486-2021 | SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. | The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences). | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain