VITEK¿ 2 Systems Software Version 9.01 Update Kit recall: Software Issue
VITEK¿ 2 Systems Software Version 9.01 Update Kit.
Why was VITEK¿ 2 Systems Software Version 9.01 Update Kit recalled?
The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK¿ 2 FLEXPREP" feature.
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?
Product Description: KIT UPDT VTK2 9.01 EN, UDI: 03573026561260
- Product
- VITEK¿ 2 Systems Software Version 9.01 Update Kit.
- Recalling firm
- bioMerieux, Inc.
- Quantity
- five (5) VITEK¿ 2 Systems Software version 9.01
- Distribution
- Nationwide distribution to CO, IL, MO, TX.
- Recall date
- December 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)