FDAClass IIIOctober 30, 2013

Alere Triage¿ TOX Drug Screen Control 1 Product Generic recall

Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests…

Why was Alere Triage¿ TOX Drug Screen Control 1 Product Generic recalled?

Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the control to fail when run in the QC Sample Mode using Alere Triage TOX Drug Screeen products. The Alere Triage TOX Drug Screen test devices and patient results are not affected.

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?

Part Number 94413. Lot Number C2681A.

Product
Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests…
Recalling firm
Alere San Diego, Inc.
Quantity
38
Distribution
Worldwide Distribution - USA (nationwide) and countries of: South Africa and Canada.
Recall date
October 30, 2013
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls