Alere San Diego, Inc.: Alere Triage TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage TOX Drug Screen Control 1 or Alere Triage TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage TOX Drug Screen Controls are to be used with the Alere Triage TOX Drug Screen tests and Alere Triage Meters to assist the laboratory in monitoring test performance.

Recall number

Z-0053-2014

Recalling firm

Alere San Diego, Inc.

Product

Alere Triage TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage TOX Drug Screen Control 1 or Alere Triage TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage TOX Drug Screen Controls are to be used with the Alere Triage TOX Drug Screen tests and Alere Triage Meters to assist the laboratory in monitoring test performance.

Status

Terminated

Initiated

2013-09-23

Posted

2013-10-23

Terminated

2014-09-26

Reason

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.

Root cause

Under Investigation by firm

Action

Alere San Diego, Inc. sent an Urgent Medical Device Notice dated September 23, 2013, to all affected customers via FedEx and outside US (OUS) consignees on September 24, 2013, via email. The customer notification letter titled "URGENT MEDICAL DEVICE NOTICE", informed customers of the recall, product description with part number and lot code (Alere Triage TOX Drug Screen Control 1 PN 94413 Lot C2681A), reason for recall and impact (The purpose of the letter was to inform customers that 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 Screen products. Customers were instructed to discontinue use of and discard the CODE CHIP contained within the Alere Triage TOX Drug Screen Control 1 PN 94413 Lot C2681A kit box. Customers were also instructed to provide a copy of the notice to their customers and instruct them to contact Alere for a replacement code chip. Customers were asked to complete and fax the enclosed Verification Form to confirm their receipt of the notice. Customers with questions were instructed to contact: (Alere San Diego, Inc. 9975 Summers Ridge Road San Diego, CA 92121, U.S.A. Phone: 877 308 8287 FAX: 858 805 8457 E-mail: Responses.ts@alere.com). For questions regarding this recall call 858-805-2000, ext 3015.

Quantity

38

Distribution

Worldwide Distribution - USA (nationwide) and countries of: South Africa and Canada.

Lot, serial or model codes

Part Number 94413. Lot Number C2681A.

510(k) numbers

["K060788"]

PMA numbers

not on file

Product code

DIF

Firm FEI

1000125596

Firm city

San Diego

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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