FDA recall Z-0074-2018

Biomerieux Inc · Class II · device

Product

VITEK2 GP-ID, REF 21342 IVD

Reason for recall

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.

Distribution

worldwide

Key facts

Status: Terminated
Initiation date: 2017-10-11
Report date: 2017-11-15
Termination date: 2020-11-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hazelwood, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0074-2018