FDAClass IIFebruary 27, 2019

VITEK 2 AST-N351 Test Kit recall

VITEK 2 AST-N351 Test Kit

Why was VITEK 2 AST-N351 Test Kit recalled?

False Positive ESBL Phenotype

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?

Ref: 421257 ALL LOTS

Product
VITEK 2 AST-N351 Test Kit
Recalling firm
bioMerieux, Inc.
Quantity
30,292 cartons (20 cards per carton)
Distribution
UK and Ireland
Recall date
February 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls