Z-2460-2012Class II

Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence...

Name: Z-2460-2012 Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence...
Creator: Alere San Diego, Inc.
Published: 2012-07-12
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2012-07-12 / Terminated / root cause: manufacturing process

FDA source

Alere San Diego, Inc. began a recall of 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... on 2012-07-12. FDA classified it as Class II and gives the reason as "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...". 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-2460-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-12
Posted: 2012-09-26
Terminated: 2013-02-01
Recalling firm: Alere San Diego, Inc.
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.
Product code: LDP Colorimetry, Acetaminophen
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected].
Quantity in commerce: 591 kits
Distribution: Nationwide Distribution.
Product codes and lots: Lot Codes: K51245RB, W51022RB, W51207RB

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2460-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2460-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-26

Product code LDP

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)