Z-0074-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2017
- Initiation Date
- October 11, 2017
- Termination Date
- November 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5672 cartons
Product Description
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 Pattern
worldwide
Code Information
UDI 03573026131920, Lot Number 2420348103