FDA-Device2017-11-15Class II
VITEK2 GP-ID, REF 21342 IVD
Biomerieux Inc
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.
Sold states
worldwide
Affected count
5672 cartons
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
VITEK2 GP-ID, REF 21342 IVD
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0074-2018Don't want to check this manually?
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