Z-2039-2012Class II

Alere Triage Tox+MTD Drug Screen, PN 94400

Name: Z-2039-2012 Alere Triage Tox+MTD Drug Screen, PN 94400
Creator: Alere San Diego, Inc.
Published: 2012-05-14
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2012-05-14 / Terminated / root cause: manufacturing process

FDA source

Alere San Diego, Inc. began a recall of 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... on 2012-05-14. FDA classified it as Class II and gives the reason as "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...". 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-2039-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-14
Posted: 2012-07-19
Terminated: 2012-12-04
Recalling firm: Alere San Diego, Inc.
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.
Product code: DJR Enzyme Immunoassay, Methadone
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.
Root cause tag: manufacturing process
FDA root 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2039-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2039-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19

Product code DJR

K060791Class IITriage Tox Drug Screen, Model 94400Biosite Incorporated / cleared 2006-06-22

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)