Z-1088-2009

Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitative...

Name: Z-1088-2009 Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitative...
Creator: Biosite Inc
Published: 2008-11-06
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2008-11-06 / Terminated

FDA source

Biosite Inc began a recall of Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of... on 2008-11-06. The reason FDA records is "The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive PCP results has exceeded their post...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1088-2009
Status: Terminated
Initiated: 2008-11-06
Posted: 2009-03-17
Terminated: 2011-10-13
Recalling firm: Alere San Diego, Inc.
Product: Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine.
Product code: DKZ Enzyme Immunoassay, Amphetamine
Reason for recall: The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive PCP results has exceeded their post market surveillance thresholds for customer complaints in the field. In addition, the firm has been able to reproduce false positive results reported by customers and as a result
FDA root cause: Other
Action: Consignee notification was initiated on 11/6/2008 with Urgent Medical Device Recall notifications, dated 11/5/2008 and mailed to domestic customers sent via US Postal Service Priority Mail and to foreign customers via FedEx. The notice informed customers of the reason for the recall and requested the customers immediately discontinue all use of lot #186625 and discard all affected product in accordance with your local regulations. The customers were also instructed to complete and fax an attached Customer/Distributor Verification form within 10 days.
Quantity in commerce: 2634 kits
Distribution: Worldwide Distribution -- USA and country of Canada.
Product codes and lots: Lot/Unit Codes: 186625

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)