FDAClass IINovember 23, 2016

Alere Triage Total 5 Control Level 1 recall

Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are…

Why was Alere Triage Total 5 Control Level 1 recalled?

Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value 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?

C3233A

Product
Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are…
Recalling firm
Alere San Diego, Inc.
Quantity
513 kits
Distribution
US Nationwide Distribution
Recall date
November 23, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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