FDAClass IIApril 1, 2020

VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is recall

VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the…

Why was VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is recalled?

The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.

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: 422024 Lot Number: 0210932204

Product
VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the…
Recalling firm
bioMerieux, Inc.
Quantity
4,130 kits (82,600 cards)
Distribution
International distribution in the countries of Germany and the Netherlands.
Recall date
April 1, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls