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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Product Detail

Product Description 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
Classification Class III
Code Info Part Number 94413. Lot Number C2681A.
Product Distributed Qty 38
Reason For Recall 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.

Event Detail

Event Id 66394
Product Type Devices
Status Ongoing
Recalling Firm Alere San Diego, Inc.
City San Diego
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-23
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution - USA (nationwide) and countries of: South Africa and Canada
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