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Biomerieux Inc recalls VITEK2 GP-ID, REF 21342 IVD

Recalled November 15, 2017 · FDA recall Z-0074-2018 · Biomerieux

Hazard
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. · FDA Class II
Units
5672 cartons
Sold at
worldwide

Description

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.

Product
VITEK2 GP-ID, REF 21342 IVD
Manufacturer(s)
Biomerieux Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Biomerieux Inc recalls VITEK2 GP-ID, REF 21342 IVD | RecallWatchUSA