Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitative determination of t
FDA device recall Z-1088-2009 · posted 2009-03-17 · Terminated
Recall details
- Recalling firm
- Biosite Inc
- 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
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DKZ
- Quantity affected
- 2634 kits
- Distribution
- Worldwide Distribution -- USA and country of Canada.
- Date initiated
- 2008-11-06
- Date posted
- 2009-03-17
- Date terminated
- 2011-10-13
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS (K973784) | Biosite Incorporated | 1997-12-03 |