bioMerieux product recalled over mold contamination

Recall date

March 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

bioMerieux, Inc. recalls Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards design…

Recall number

Z-1137-2019

FDA classification

Class II

Brand / firm

bioMerieux, Inc.

Sold / distributed

Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.

Why it was recalled

Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254, AST-N330, AST-N371 (ref.413723,418674, 422024) test kits.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.