Recall Z-0733-2007 ยท DKZ Enzyme Immunoassay, Amphetamine
Bio-Rad Laboratories Inc
Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA
| Date | Apr 10, 2007 (initiated Feb 12, 2007) |
| Status | Terminated |
| Reason | The product may produce a faint line which could be interpreted as a false negative test result . |
| Root cause | Other |
| Action | 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. |
| Quantity | 177 Kits |
| Distribution | Worldwide distribution --- USA and countries of Australia and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031759 | ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD ACON Laboratories, Inc., Aug 4, 2003 |