Microbiologics Inc
Microbiologics Inc appears in FDA public data with 66 recalls, 18 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0984-2026, Class II) was initiated on December 2, 2025. Its most recent 510(k) clearance was granted on October 7, 2019.
Summary
- Total Recalls
- 66
- 510(k) Clearances
- 18
- Inspections
- 4
- Compliance Actions
- 0
Known Names
microbiologics, micro-bio-logics
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0984-2026 | Class II | KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P | December 2, 2025 |
| Z-0986-2026 | Class II | LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L | December 2, 2025 |
| Z-0985-2026 | Class II | KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K | December 2, 2025 |
| Z-0876-2026 | Class II | KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, C | November 13, 2025 |
| Z-2194-2025 | Class II | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pa | June 27, 2025 |
| Z-2195-2025 | Class II | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L | June 27, 2025 |
| Z-2124-2025 | Class II | KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L | June 17, 2025 |
| Z-1957-2025 | Class II | KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis d | May 27, 2025 |
| Z-1371-2025 | Class II | Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unass | February 20, 2025 |
| Z-1454-2025 | Class II | Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-a | February 20, 2025 |
| Z-1164-2025 | Class II | Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF | January 20, 2025 |
| Z-1163-2025 | Class II | Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; | January 20, 2025 |
| Z-1483-2024 | Class II | KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality co | March 6, 2024 |
| Z-1075-2024 | Class II | Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. | January 8, 2024 |
| Z-0307-2024 | Class II | KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack) | October 18, 2023 |
| Z-0308-2024 | Class II | LYFO-DISK, P. venetum, Catalog number 0794L | October 18, 2023 |
| Z-2576-2023 | Class III | KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing | August 14, 2023 |
| Z-1740-2022 | Class III | Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF | July 27, 2022 |
| Z-1125-2022 | Class III | KWIK-STIK" plus: Clostridium perfringens | May 6, 2022 |
| Z-0954-2022 | Class II | Inactivated macrolide and quinolone-resistant Mycoplasma genitalium | March 24, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K190086 | Cepheid Xpert Respiratory Control Panel | October 7, 2019 |
| K191168 | Cepheid Xpert SA Nasal Complete Control Panel | June 25, 2019 |
| K191172 | Cepheid Xpert MRSA NxG Control Panel | June 20, 2019 |
| K190223 | Cepheid Xpert CT/NG Control Panel | May 8, 2019 |
| K190463 | Cepheid Xpert C. difficile/Epi Control Panel | April 19, 2019 |
| K182472 | Cepheid Xpert GBS LB Control Panel | November 8, 2018 |
| K181683 | BD MAX CT/GC/TV 20-Day QC Panel | August 28, 2018 |
| K181711 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel | August 15, 2018 |
| K970009 | LYFO(TM) DIFFERENTIAL DISK-BACITRACIN | February 6, 1997 |
| K954812 | LYFO(TM) DIFFERIENTAL DISK-PYR | December 20, 1995 |
| K951889 | LYFO(TM) DIFFERENTIAL DISK | August 24, 1995 |
| K945487 | LYFO(TM) DIFFERENTIAL DISK | May 11, 1995 |
| K945488 | LYFO(TM) DIFFERENTIAL DISK | May 11, 1995 |
| K945489 | LYFO(TM) DIFFERENTIAL DISK | May 11, 1995 |
| K945883 | LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN | April 24, 1995 |
| K945881 | LYFO(TM) DIFFERENTIAL DISK-STERILE DISK | April 24, 1995 |
| K945882 | LYFO(TM) DIFFERENTIAL DISK-BILE | April 24, 1995 |
| K945880 | LYFO(TM) DIFFERENTIAL DISK-SPS | April 24, 1995 |