Microbiologics recalls

Microbiologics has 66 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 31 Dec 2025. 20 are still ongoing. 4 were reported in the last 12 months.

Total recalls66since 2012
Last 12 months4reported
Class I00% of total
Ongoing20latest 31 Dec 2025

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 54 82%Class III 12 18%

By year

Ongoing microbiologics recalls

20 active

All microbiologics recalls, newest first

66 total
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IILyfo Disk, Campylobacter jejuni subsp recalled by MicrobiologicsMicrobiologicsOther Bacterial ContaminationNationwide
DeviceCLASS IIKwik-stik, Campylobacter jejuni subsp recalled by MicrobiologicsMicrobiologicsOther Bacterial ContaminationNationwide
DeviceCLASS IIKwik-stik, Campylobacter jejuni subsp recalled by MicrobiologicsMicrobiologicsOther Bacterial ContaminationNationwide
DeviceCLASS IIKwik-stik, Quality control kit for culture media recalledMicrobiologicsPackaging DefectsMN
DeviceCLASS IILyfo-disk, M. Canis Derived from Atcc 36299, packaged as recalledMicrobiologicsDevice MalfunctionNationwide
DeviceCLASS IILyfo-disk, M. Canis Derived from Atcc 36299, packaged as recalledMicrobiologicsDevice MalfunctionNationwide
DeviceCLASS IIKwik-stik and Lyfo Disk, quality control kit for culture media recalledMicrobiologicsOther Bacterial ContaminationOH, UT
DeviceCLASS IIKwik-stick, Quality control kit for culture media recalledMicrobiologicsPackaging DefectsNationwide
DeviceCLASS IIHelix Elite Inactivated Standard recalled by MicrobiologicsMicrobiologicsPotency & AssayNationwide
DeviceCLASS IIHelix Elite" Inactivated Standard recalled by MicrobiologicsMicrobiologicsPotency & AssayNationwide
DeviceCLASS IIMulti-Strain Human Papillomavirus (HPV) Verification Panel recalledMicrobiologicsPotency & AssayNationwide
DeviceCLASS IIMulti-Strain Human Papillomavirus (HPV) Control Panel recalledMicrobiologicsPotency & AssayNationwide
DeviceCLASS IIKwik-stik Rhizopus stolonifer (+) derived from Atcc 6227b, a) recalledMicrobiologicsOtherNationwide
DeviceCLASS IIEnteric Pathogens Control Panel (Inactivated Pellet) recalledMicrobiologicsNorovirusNationwide
DeviceCLASS IILyfo-disk, P recalled by MicrobiologicsMicrobiologicsOtherNationwide
DeviceCLASS IIKwikstik, P. venetum recalled by MicrobiologicsMicrobiologicsOtherNationwide
DeviceCLASS IIIKwik-stik, ANA (3 Strains) QC Set recalled by MicrobiologicsMicrobiologicsOtherNationwide
DeviceCLASS IIIHelix Elite Inactivated Standard, labeled as recalled by MicrobiologicsMicrobiologicsOtherMN
DeviceCLASS IIIKwik-stik" plus: Clostridium perfringens recalled by MicrobiologicsMicrobiologicsLabeling ErrorsNationwide
DeviceCLASS IIInactivated macrolide-resistant Mycoplasma genitalium recalledMicrobiologicsOtherNationwide
DeviceCLASS IIInactivated macrolide and quinolone-resistant Mycoplasma genitalium recalledMicrobiologicsOtherNationwide
DeviceCLASS IIPneumonia (33 Targets) Control Panel recalled by MicrobiologicsMicrobiologicsPotency & Assay8 states
DeviceCLASS IIMycoplasma genitalium Control Panel (Inactivated Pellet) recalledMicrobiologicsOther18 states
DeviceCLASS IIILYFO Disk recalled by MicrobiologicsMicrobiologicsOther Bacterial ContaminationNationwide
DeviceCLASS IIHelix Elite" Molecular Standards: Inactivated Standard recalledMicrobiologicsOtherNationwide
DeviceCLASS IILyfo-disk, Quality control kit for culture media, sold as recalledMicrobiologicsOtherNationwide
DeviceCLASS IIQC Sets and Panels recalled by MicrobiologicsMicrobiologicsOtherNationwide
DeviceCLASS IIQC Sets and Panels: Kwik-stik recalled by MicrobiologicsMicrobiologicsDevice MalfunctionNationwide
DeviceCLASS IIKwik-stik, Quality control kit for culture media, sold as recalledMicrobiologicsOtherNationwide
DeviceCLASS IIHelix Elite" Molecular Standards: Inactivated Standard recalledMicrobiologicsPotency & AssayNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.