FDAClass IIMay 11, 2016

VITEK 2 Gram Positive Susceptibility Test Cards recall

VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an…

Why was VITEK 2 Gram Positive Susceptibility Test Cards recalled?

Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.

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?

Lot/Serial: 485368220 Expiry: 12-JAN-17

Product
VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an…
Recalling firm
Biomerieux Inc
Quantity
337 Kits of 20 Cards/Kit
Distribution
Worldwide Distribution to China  Taiwan region; No US/military/government distribution.
Recall date
May 11, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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