Recall Z-0521-2012 ยท DKZ Enzyme Immunoassay, Amphetamine
Alere San Diego
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.
| Date | Jan 11, 2012 (initiated Jul 1, 2011) |
| Status | Terminated |
| Reason | 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 | 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 d |
| Quantity | 997 total kits |
| Distribution | Worldwide Distribution -- US and to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973784 | TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS Biosite Incorporated, Dec 3, 1997 |