FDAOctober 8, 2020device

Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for the detection and identification of a cultured microorganism isolate.

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

The hazard

Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.

What to do

FDA enforcement status: Terminated

Brands named

microbiologics

UPCs

20845357040446

Recall history

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

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