Microbiologics Inc recalls
7 recalls on record · FDA
Every recall we have on record for Microbiologics Inc, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole…
Product not registered for use in the UK
KWIK-STIK" plus: Clostridium perfringens
Labeling error.
LYFO Disk
LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack)…
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification…
Real-time shelf life testing failed at 24 months
LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit…
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains…
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.