Microbiologics Inc

FDA Regulatory Profile

Summary

Total Recalls
66
510(k) Clearances
18
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0984-2026Class IIKWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325PDecember 2, 2025
Z-0986-2026Class IILYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325LDecember 2, 2025
Z-0985-2026Class IIKWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325KDecember 2, 2025
Z-0876-2026Class IIKWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, CNovember 13, 2025
Z-2195-2025Class IILYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894LJune 27, 2025
Z-2194-2025Class IILYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-paJune 27, 2025
Z-2124-2025Class IIKWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805LJune 17, 2025
Z-1957-2025Class IIKWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis dMay 27, 2025
Z-1371-2025Class IIHelix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassFebruary 20, 2025
Z-1454-2025Class IIHelix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-aFebruary 20, 2025
Z-1163-2025Class IIMicrobiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234;January 20, 2025
Z-1164-2025Class IIMicrobiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF January 20, 2025
Z-1483-2024Class IIKWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality coMarch 6, 2024
Z-1075-2024Class IIMicrobiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.January 8, 2024
Z-0307-2024Class IIKWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)October 18, 2023
Z-0308-2024Class IILYFO-DISK, P. venetum, Catalog number 0794LOctober 18, 2023
Z-2576-2023Class IIIKWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testingAugust 14, 2023
Z-1740-2022Class IIIHelix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REFJuly 27, 2022
Z-1125-2022Class IIIKWIK-STIK" plus: Clostridium perfringensMay 6, 2022
Z-0954-2022Class IIInactivated macrolide and quinolone-resistant Mycoplasma genitaliumMarch 24, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K190086Cepheid Xpert Respiratory Control PanelOctober 7, 2019
K191168Cepheid Xpert SA Nasal Complete Control PanelJune 25, 2019
K191172Cepheid Xpert MRSA NxG Control PanelJune 20, 2019
K190223Cepheid Xpert CT/NG Control PanelMay 8, 2019
K190463Cepheid Xpert C. difficile/Epi Control PanelApril 19, 2019
K182472Cepheid Xpert GBS LB Control PanelNovember 8, 2018
K181683BD MAX CT/GC/TV 20-Day QC PanelAugust 28, 2018
K181711BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC PanelAugust 15, 2018
K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINFebruary 6, 1997
K954812LYFO(TM) DIFFERIENTAL DISK-PYRDecember 20, 1995
K951889LYFO(TM) DIFFERENTIAL DISKAugust 24, 1995
K945489LYFO(TM) DIFFERENTIAL DISKMay 11, 1995
K945487LYFO(TM) DIFFERENTIAL DISKMay 11, 1995
K945488LYFO(TM) DIFFERENTIAL DISKMay 11, 1995
K945883LYFO(TM) DIFFERENTIAL DISK-BILE ESCULINApril 24, 1995
K945881LYFO(TM) DIFFERENTIAL DISK-STERILE DISKApril 24, 1995
K945880LYFO(TM) DIFFERENTIAL DISK-SPSApril 24, 1995
K945882LYFO(TM) DIFFERENTIAL DISK-BILEApril 24, 1995