Biomerieux Inc recalls VITEK2 GP-ID, REF 21342 IVD

Recall date

October 11, 2017

Source

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

Recall number

Z-0074-2018

FDA classification

Class II

Brand / firm

Biomerieux Inc

Sold / distributed

worldwide

Why it was recalled

Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3) VITEK(R) 2 GP ID Lots, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. In accordance with the VITEK(R) 2 GP ID Instructions For Use, the expected O129R reaction for ATCC(R) 700327(TM) strain is positive. As a precaution, bioM¿rieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials.

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

What was recalled

VITEK2 GP-ID, REF 21342 IVD