FDAClass IIOctober 3, 2012

Alere Triage TOX Drug Screen 9 Panel recall

Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere…

Why was Alere Triage TOX Drug Screen 9 Panel recalled?

Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP, BAR, and PCP, the threshold ranges may not be consistently set correctly in all meters.

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 Codes: K51245RB, W51022RB, W51207RB

Product
Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere…
Recalling firm
Alere San Diego, Inc.
Quantity
591 kits
Distribution
Nationwide Distribution.
Recall date
October 3, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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