Vitek2 Gp-id recall
VITEK2 GP-ID, REF 21342 IVD
Why was Vitek2 Gp-id 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 03573026131920, Lot Number 2420348103
- Product
- VITEK2 GP-ID, REF 21342 IVD
- Recalling firm
- Biomerieux Inc
- Quantity
- 5672 cartons
- Distribution
- worldwide
- Recall date
- November 15, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)