Z-1130-2012

Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of Abuse Panel Plus TCA...

Name: Z-1130-2012 Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of Abuse Panel Plus TCA...
Creator: Alere San Diego
Published: 2012-01-04
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2012-01-04 / Terminated / root cause: manufacturing process

FDA source

Alere San Diego began a recall of 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... on 2012-01-04. The reason FDA records is "Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1130-2012
Status: Terminated
Initiated: 2012-01-04
Posted: 2012-03-01
Terminated: 2013-07-05
Recalling firm: Alere San Diego, Inc.
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.
Product code: DIS Enzyme Immunoassay, Barbiturate
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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

Product code DIS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)