Z-0418-2018Class II

Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched...

Name: Z-0418-2018 Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched...
Creator: Alere San Diego, Inc.
Published: 2017-11-14
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2017-11-14 / Completed / root cause: manufacturing process

FDA source

Alere San Diego, Inc. began a recall of Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette and 50... on 2017-11-14. FDA classified it as Class II and gives the reason as "The recalled lots have demonstrated unexpected false positive THC results". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0418-2018
Classification: Class II
Status: Completed
Initiated: 2017-11-14
Posted: 2018-01-26
Recalling firm: Alere San Diego, Inc.
Product: Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box. Product Usage: The Alere Triage Drugs of Abuse Panel plus Tricyclic Antidepressants uses eight discrete competitive immunoassay procedures for the simultaneous detection and identification of the major drugs and/or the urinary metabolites of eight different drug classes. The use of monoclonal antibodies that are specific for the drugs and/or metabolites of the eight drug classes ensures a high degree of sensitivity and specificity.
Product code: DKZ Enzyme Immunoassay, Amphetamine
Reason for recall: The recalled lots have demonstrated unexpected false positive THC results.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: All primary consignees will be contacted in letter provided via fax, email or direct mail. End users will be instructed to discard any remaining inventory they may have of the affected lots. Alere will provide credit to end users for any remaining unused inventory.
Quantity in commerce: 2940 units
Distribution: Worldwide distribution - United States Nationwide and the countries of Japan, Canada
Product codes and lots: Lots 403111, 406741, 396588, 398577, 396587

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0418-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0418-2018	Class II	Completed	Voluntary: Firm initiated	2018-02-07	2018-01-26

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