The VITEK¿ 2 Gram Positive Susceptibility Card is recall
The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine…
Why was The VITEK¿ 2 Gram Positive Susceptibility Card is recalled?
A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
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?
VITEK¿ 2 AST-P606 (ref: 22330): Lot Number 4860117403
- Product
- The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine…
- Recalling firm
- BioMerieux SA
- Quantity
- 5 boxes with AST-P606 TEST KIT 20 CARDS
- Distribution
- International distribution.
- Recall date
- June 20, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)