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U.S. Department of Health and Human Services

Class 3 Device Recall Quality Control Material

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  Class 3 Device Recall Quality Control Material see related information
Date Initiated by Firm September 23, 2013
Date Posted October 23, 2013
Recall Status1 Terminated 3 on September 26, 2014
Recall Number Z-0053-2014
Recall Event ID 66394
510(K)Number K060788  
Product Classification Drug mixture control materials - Product Code DIF
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.
Code Information Part Number 94413. Lot Number C2681A.
Recalling Firm/
Manufacturer		 Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact
858-805-2000 Ext. 3015
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 38
Distribution Worldwide Distribution - USA (nationwide) and countries of: South Africa and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DIF and Original Applicant = BIOSITE INCORPORATED
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