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U.S. Department of Health and Human Services

Class 2 Device Recall Drugs of Abuse Screen

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  Class 2 Device Recall Drugs of Abuse Screen see related information
Date Initiated by Firm February 05, 2014
Date Posted March 17, 2014
Recall Status1 Terminated 3 on October 27, 2014
Recall Number Z-1214-2014
Recall Event ID 67529
510(K)Number K060791  
Product Classification Enzyme immunoassay, methadone - Product Code DJR
Product Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B.

25 individually pouched devices in a labeled kit box.

Indications for use: 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 Catalog Number 94400, Lots W56013B and W56035B
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. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these lots have a frequency of false negative results for PCP (Phencyclidine) that is higher than the frequency shown in the package insert. If you have questions about previously reported results.
FDA Determined
Cause 2		 Process control
Action Alere San Diego, Inc. sent out recall notification letters to customers via direct mail or email. The letter, dated February 3, 2014, titled "URGENT MEDICAL DEVICE RECALL", provided customers the following information: product description with codes, reason for recall, impact, contact information and customer/distributor required actions. A Customer/Distributor Verification Form was provided. Customers were instructed to discontinue use and discard the affected lots. Alternately, if you elect to continue to use the product customers must verify if it will not be used to report results for PCP. Customers were instructed to return the Customer Verification Form by fax to 858-805-8457 with the amount of product they have for credit. The information should be shared with their laboratory staff and the notification should be retained as part of their laboratory Quality System documentation. If the product has been forwarded customers were instructed to provide a copy of the letter to them. Customers with questions were instructed to contact Alere San Diego, Inc. at 877-308-8287 or email Triage.Support@alere.com. For questions regarding this recall call 858-805-2000, ext 3015.
Quantity in Commerce 305 kits (239 kits of W56013B, 66 kits of W56035B)
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Taiwan.
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
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