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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 January 04, 2012
Date Posted March 01, 2012
Recall Status1 Terminated 3 on July 05, 2013
Recall Number Z-1130-2012
Recall Event ID 60980
510(K)Number K924476  K973784  /K014247  
Product Classification Enzyme immunoassay, barbiturate - Product Code DIS
Product Product Brand Names: Triage¿ Drugs of Abuse Panel 8 Test Kit (K924476), Triage¿ Drugs of Abuse
Panel Plus TCA (K973784), & Triage¿ Drugs of Abuse Panel Plus PPX (K014247)
Model Number: 90008, 92002, & 92000
Type of Packaging (i.e. box, plastic bag): For all affected device types: 25 individually pouched devices
in a labeled kit box.

The Triage¿ Drugs of Abuse Panel plus Tricyclic Antidepressants utilizes a patented immunochemistry,
ASCENDTM MULTIMMUNOASSAY¿ (AMIATM). Each AMIATM assay is a competitive binding immunoassay
in which a chemically labeled drug (drug conjugate) competes with drug which may be present in the urine for
antibody binding sites. After a brief incubation, the reaction mixture is transferred to the membrane in the
Detection Area. Free drug conjugate that is displaced from antibody binding sites by drug in the urine, binds to a
zone of monoclonal antibody that is immobilized on the membrane. The membrane is washed to remove the
unbound conjugate and clear the background. Test results are visually read.

The Triage¿ Drugs of Abuse Panel plus Tricyclic Antidepressants is an immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse, (Phencyclidine, Benzodiazepines, Cocaine Metabolite, Amphetamines, THC, Opiates, Barbiturates), and Tricyclic Antidepressants in urine.
Code Information Part 90008: lot 259403 exp 02/03/13, lot 267081 exp 05/08/13 Part 92000: lots 254662, 255830, 257527, 262143 with exp 01/06/13; lots 259628, 259954 with exp 02/03/13 Part 92002: lot 234295 exp 02/03/13 
Recalling Firm/
Manufacturer		 Alere San Diego
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact
858-455-4808 Ext. 3015
Manufacturer Reason
for Recall		 Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Alere sent a "PRODUCT NOTIFICATION" letter dated January 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Verification Form was enclosed for customers to complete and return to the firm. Contact Technical Services at 1-877-308-8287.
Quantity in Commerce 693054 kits
Distribution Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, EU, Guatemala, Japan, Lebanon, and Saudi Arabia.
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 = DIS and Original Applicant = BIOSITE INCORPORATED
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