Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories
FDA device recall Z-0733-2007 · posted 2007-04-10 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories Inc
- Reason for recall
- The product may produce a faint line which could be interpreted as a false negative test result .
- Action taken
- The firm intends to contact its subsidiary distributors and sales staff via Fax (Feb 12, 2007) and phone call. In addition, the recall notification will be posted on the firm's intranet site. Customers are instructed to destroy recalled product following standard laboratory practices.
- Root cause
- Other
- Status
- Terminated
- Product code
- DKZ
- Quantity affected
- 177 Kits
- Distribution
- Worldwide distribution --- USA and countries of Australia and Italy.
- Date initiated
- 2007-02-12
- Date posted
- 2007-04-10
- Date terminated
- 2008-02-04
- Location
- Hercules, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD (K031759) | ACON Laboratories, Inc. | 2003-08-04 |