BioMerieux SA recalls ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial suscepti…

Recall date

April 13, 2017

Source

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

Recall number

Z-0264-2018

FDA classification

Class II

Brand / firm

BioMerieux SA

Sold / distributed

Worldwide Distribution - USA (nationwide) and to the countries of : Algeria, Austria, Australia, Belarus, Bosnia-Herz., Canada, Croatia, Czech Republic, Egypt, Estonia, France, Georgia, Germany, Greece, Guam, Hong Kong, Hungary, India, Israel, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Netherlan…

Why it was recalled

QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.

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

What was recalled

ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.