Class 2 Device Recall Alere Triage ToxMTD Drug Screen

• Date Initiated by Firm: May 14, 2012
• Date Posted: July 19, 2012
• Recall Status: Terminated on December 04, 2012
• Recall Number: Z-2039-2012
• Recall Event ID: 62293
• 510(K)Number: K060791
• Product Classification: Enzyme immunoassay, methadone - Product Code DJR
• Product: Alere Triage Tox+MTD Drug Screen, PN 94400; ; Product Usage:; The Alere Triage TOX Drug Screen is a fluorescence immunoassay 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, methadone, 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. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.
• Code Information: Lot/Unit Codes: W50216B, W50222B, W50245B, W50250B, W50809B, W50810B, W50812B, W50813B, W50816B, W50817B, W50818B, W50819B, W50820B, W50821B, W50822B, W50823B, W50826B, W50829B, W50830B, W50831B, W50832B, W50837B, W50838B, W50842B, W50843B, W50844B, W50846B, W50848B, W50851B, W50862B, W50866B, W50869B, W50870B, W50871B, W50872B, W50873B.
• 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: A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than claimed. An increased frequency of false positive and/or false negative results has been observed for Triage TOX Drug Screen.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Alere sent an Urgent Medical Device Recall letter dated June 11, 2012 to all affected customers. The letter informed the customers of the affected product, problem identified and actions to be taken. Customers were instructed to discontinue all use of the recalled lots, immediately inform clinicians of this recall at the testing site(s) and complete and fax the enclosed customer verification form and list of affected lots within 10 days to confirm receipt of the letter. Customers with questions about the information contained in the recall letter, can contact Alere San Diego at 9975 Summers Ridge Road, San Diego, CA 92121 or call (877) 308-8287.
• Quantity in Commerce: 9,997 kits
• Distribution: US 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 = DJR and Original Applicant = BIOSITE INCORPORATED