medical Class II Updated 2022-02-16

Microbiologics Inc recalls QC Sets and Panels, KWIK-STIK Blood Culture Identification (

Recalled Product

QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Catalog Number: 5229P; Lot Numbers (Expiration Date): 5229-01 (07/31/2020), 5229-02 (09/30/2020), 5229-03 (09/30/2020); UDI: 70845357038899

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