QC Control Materials KWIK-STIK AST-GP Produce Incorrect Test Results
Microbiologics Inc recalls KWIK-STIK AST-GP quality control materials that produce incorrect antibiotic susceptibility test results. Two lot numbers were distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported patient illness or injury. The hazard is theoretical—defective quality control materials could produce incorrect test results, affecting the reliability of antibiotic susceptibility testing. Per the rubric, risk-of-harm products without reported injury score at 3 (High).
Plain-English summary
Microbiologics Inc has recalled KWIK-STIK AST-GP (4 Strains) QC Set, Catalog Number 5112P, a quality control material used in antibiotic susceptibility testing. Two affected lots were distributed worldwide: Lot 5112-01 (Expiration 07/31/2020) and Lot 5112-02 (Expiration 10/31/2020).
The recall was issued because these quality control materials produce incorrect test results. Specifically, High Level Gentamicin Synergy values tested out of specification when analyzed on the Vitek 2 AST-GP67 card, and the lots failed the disk diffusion method used for product release.
The affected materials were distributed worldwide to clinical and research laboratories that use these quality control materials to validate antibiotic susceptibility testing.
The recalled product
- Product
- 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
- Manufacturer
- Microbiologics Inc
- Hazard
- test-inaccuracy
- quality-control-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog Number: 5112P
- Lot Numbers: 5112-01 (Expiration Date 07/31/2020)
- 5112-02 (Expiration Date 10/31/2020)
- UDI: 70845357026551
Distribution
Distributed nationwide across the United States.
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