FDA Medical Device Recalls (openFDA)
Bio-Rad Laboratories Inc: Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216, 194-5223
- Recall number
- Z-0289-06
- Recalling firm
- Bio-Rad Laboratories Inc
- Product
- Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216, 194-5223
- Status
- Terminated
- Initiated
- 2004-06-04
- Posted
- 2005-12-15
- Terminated
- 2006-04-14
- Reason
- The device was producing false negative results for cocaine tests.
- Root cause
- Other
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- 9450311-1, 9450319, 9450545, 9450547, 9450311, 9451356, 94532016CE
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DIO
- Firm FEI
- 2915274
- Firm city
- Hercules
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28