Microbiologics Inc 2022-02-16 Health serious FDA
Health · FDA · Recall #FDA-Z-0587-2022
QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains… Recall
Issued February 16, 2022 · Microbiologics Inc
In February 2022, Microbiologics Inc recalled the QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Microbiologics Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Microbiologics Inc
- Category
- Health
- Recall date
- February 16, 2022
- Units affected
- Not reported
- Sold at
- Worldwide Distribution. US nationwide including Puerto Rico and Guam, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia,
- Recall number
- FDA-Z-0587-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Microbiologics Inc has 7 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.