medical Class II Updated 2022-02-16

Microbiologics Inc recalls QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets

Recalled Product

QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2.

Hazard / Issue

Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Number: 5193P; Lot Number: 5193-10 (Expiration Date 09/30/2021), 5193-11 (Expiration Date 04/30/2021); UDI: 70845357030718
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