Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216, 194-5223
FDA device recall Z-0289-06 · posted 2005-12-15 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories Inc
- Reason for recall
- The device was producing false negative results for cocaine tests.
- Action taken
- Phone calls and faxed notification forms were sent to all customers on June 4, 2004. Outside the US, subsidiaries were notified via e-mail with forms to be completed.
- Root cause
- Other
- Status
- Terminated
- Product code
- DIO
- Quantity affected
- 384 units
- Distribution
- 60 consignees received the product in the US and 6 international consignees received the product. Distribution is limited to the following countries: Canada, France, UK, Germany and Italy.
- Date initiated
- 2004-06-04
- Date posted
- 2005-12-15
- Date terminated
- 2006-04-14
- Location
- Hercules, CA
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