FDAFebruary 18, 2020device

LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

microbiologics

UPCs

10845357023237

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms — Recall Details · AllClear