Recall Z-1088-2009 ยท DKZ Enzyme Immunoassay, Amphetamine
Biosite Inc
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.
| Date | Mar 17, 2009 (initiated Nov 6, 2008) |
| Status | Terminated |
| Reason | 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 |
| 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 | 2634 kits |
| Distribution | Worldwide Distribution -- USA and country of 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 |