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U.S. Department of Health and Human Services

Class 2 Device Recall Alere Triage TOX Drug Screen 9 Panel

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  Class 2 Device Recall Alere Triage TOX Drug Screen 9 Panel see related information
Date Initiated by Firm July 12, 2012
Date Posted September 26, 2012
Recall Status1 Terminated 3 on February 01, 2013
Recall Number Z-2460-2012
Recall Event ID 63091
510(K)Number K043242  K060791  
Product Classification Colorimetry, acetaminophen - Product Code LDP
Product Alere Triage TOX Drug Screen 9 Panel, P/N: 94402.

The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.
Code Information Lot Codes: K51245RB, W51022RB, W51207RB
Recalling Firm/
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 is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP, BAR, and PCP, the threshold ranges may not be consistently set correctly in all meters.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Alere sent a 'NOTICE OF CORRECTION" letter dated July 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers with questions were instructed to contact Technical Services at (877) 308-8287. Customers were instructed to complete the Customer/Distributor Verification Form Notice of Correction even if they do not have any involved product and fax back to Technical Services at (858) 805-8457 or scan and email to responses.ts@alere.com.
Quantity in Commerce 591 kits
Distribution Nationwide Distribution.
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 = LDP and Original Applicant = BIOSITE INCORPORATED