Microbiologics, Inc.
Microbiologics, Inc. holds FDA 510(k) medical device clearances, first cleared 1995, most recent 2019, with 66 FDA device recalls on record.
Top product codes for Microbiologics, Inc.
FDA recalls by Microbiologics, Inc.
10 most recent of 66- Z-0984-2026 — KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
- Z-0986-2026 — LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
- Z-0985-2026 — KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
- Z-0876-2026 — KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
- Z-2194-2025 — LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
- Z-2195-2025 — LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
- Z-2124-2025 — KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
- 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
- Z-1454-2025 — Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
- Z-1371-2025 — Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Microbiologics, Inc.
- K190086 — Cepheid Xpert Respiratory Control Panel
- K191168 — Cepheid Xpert SA Nasal Complete Control Panel
- K191172 — Cepheid Xpert MRSA NxG Control Panel
- K190223 — Cepheid Xpert CT/NG Control Panel
- K190463 — Cepheid Xpert C. difficile/Epi Control Panel
- K182472 — Cepheid Xpert GBS LB Control Panel
- K181683 — BD MAX CT/GC/TV 20-Day QC Panel
- K181711 — BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
- K970009 — LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
- K954812 — LYFO(TM) DIFFERIENTAL DISK-PYR
- K951889 — LYFO(TM) DIFFERENTIAL DISK
- K945487 — LYFO(TM) DIFFERENTIAL DISK
- K945488 — LYFO(TM) DIFFERENTIAL DISK
- K945489 — LYFO(TM) DIFFERENTIAL DISK
- K945880 — LYFO(TM) DIFFERENTIAL DISK-SPS
- K945881 — LYFO(TM) DIFFERENTIAL DISK-STERILE DISK
- K945882 — LYFO(TM) DIFFERENTIAL DISK-BILE
- K945883 — LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN
Data sourced from openFDA. This site is unofficial and independent of the FDA.