Reported Feb 16, 2022 · Terminated
QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro…
Microbiologics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Microbiologics Inc · 200 Cooper Ave N · Saint Cloud, MN · 56303-4440
Is this the product you have?
- QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
- Lot codes and dates
- Catalog Number5112P
- Lot Numbers
5112-01 (Expiration Date 07/31/2020)5112-02 (Expiration Date 10/31/2020)
- UDI70845357026551
- Amount recalled
- 10 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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