Z-0521-2012

Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay used for the...

Name: Z-0521-2012 Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay used for the...
Creator: Alere San Diego
Published: 2011-07-01
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2011-07-01 / Terminated / root cause: manufacturing process

FDA source

Alere San Diego began a recall of Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay used for the qualitative determination of the presence of the major... on 2011-07-01. The reason FDA records is "The recall was initiated because Alere San Diego has confirmed false positive THC results obtained on Triage Drugs of Abuse Plus TCA 25 devices from lots 235991 and 238928". 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-0521-2012
Status: Terminated
Initiated: 2011-07-01
Posted: 2012-01-11
Terminated: 2012-04-04
Recalling firm: Alere San Diego, Inc.
Product: Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse and Tricyclic Antidepressants in urine.
Product code: DKZ Enzyme Immunoassay, Amphetamine
Reason for recall: The recall was initiated because Alere San Diego has confirmed false positive THC results obtained on Triage Drugs of Abuse Plus TCA 25 devices from lots 235991 and 238928.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A recall communication was initiated on July 1, 2011 with Alere San Diego forwarding a Product Notification and a Verification Form (via fax, e-mail or direct mail) to all their customers who purchased the Triage Drugs of Abuse Plus TCA 25 Test Kit, PN 9200, Lots 235991 and 238928. The letter provides the customers with an explanation of the problem identified and an action to be taken. The firm reminds customers that clinical consideration and professional judgment must be applied to any test result. Customers were instructed to retain the Product Notification letter for their records as documentation that they have received the information and to ensure that all users have a copy. Alere will replace the lots at the customer's request. As the customers complete the fax back form, they were instructed to indicate whether they wish to replace the affected product. Customers were instructed to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice. If customers have any further questions or need to report any concerns they have about the Triage Drugs of Abuse Plus TCA performance, they were instructed to contact Technical Services at (877) 308-8287 or by e-mail at [email protected].
Quantity in commerce: 997 total kits
Distribution: Worldwide Distribution -- US and to Canada.
Product codes and lots: Lots 235991 and 238928.

Product code DKZ

K973784Class IITriage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug TestsBiosite Incorporated / cleared 1997-12-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)