Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay inte
FDA device recall Z-0029-2013 · posted 2012-10-10 · Terminated
Recall details
- Recalling firm
- Alere San Diego, Inc.
- Reason for recall
- Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.
- Action taken
- Biosite sent a Notice of Correction letter dated May 28, 2009 to all their customers who purchased the Triage TOX Drug Screen. The letter informed the customers of the problem identified and actions to be taken. Customers are instructed that performance of Triage TOX Drug Screen test devices is not affected in any way by the misprinted box flap, provided the test is used with a urine sample as per the instructions for use. Customers are instructed to complete and fax the enclosed verification form within 10 days. In the US, customers were instructed to contact Biosite at (877) 441-7440 or email productadvisory@invmed.com. Customers in UK are instructed to contact European Representative, Lesley Paice, lesley.paice@invmed.com.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- DJR
- Quantity affected
- 45,638 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Colombia, Czech Republic, Finlind, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, India,
- Date initiated
- 2009-05-28
- Date posted
- 2012-10-10
- Date terminated
- 2012-10-10
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIAGE TOX DRUG SCREEN, MODEL 94400 (K060791) | Biosite Incorporated | 2006-06-22 |