FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0733-2007
- Recalling firm
- Bio-Rad Laboratories Inc
- Product
- Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA
- Status
- Terminated
- Initiated
- 2007-02-12
- Posted
- 2007-04-10
- Terminated
- 2008-02-04
- 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.
- Lot, serial or model codes
- DOA6120272
- 510(k) numbers
- ["K031759"]
- PMA numbers
- not on file
- Product code
- DKZ
- 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