medical Class II Updated 2022-02-16

Microbiologics Inc recalls LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In

Recalled Product

LYFO-DISK Enterococcus faecalis derived from ATCC 51299 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: Specific codes for Catalog Number 0959L, UDI: 10845357023237, Lot Number (Expiration Date): 959-94-1 (04/30/2020), 959-94-4 (04/30/2020), 959-95-3 (09/30/2020), 959-96-2 (12/31/2020), 959-97-3 (03/31/2021).
View official government recall

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