Z-0733-2007

Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad...

Name: Z-0733-2007 Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad...
Creator: Bio-Rad Laboratories Inc
Published: 2007-02-12
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2007-02-12 / Terminated

FDA source

Bio-Rad Laboratories Inc began a recall of Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA on 2007-02-12. The reason FDA records is "The product may produce a faint line which could be interpreted as a false negative test result". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0733-2007
Status: Terminated
Initiated: 2007-02-12
Posted: 2007-04-10
Terminated: 2008-02-04
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
Product code: DKZ Enzyme Immunoassay, Amphetamine
Reason for recall: The product may produce a faint line which could be interpreted as a false negative test result .
FDA 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 in commerce: 177 Kits
Distribution: Worldwide distribution --- USA and countries of Australia and Italy.
Product codes and lots: DOA6120272

Product code DKZ

K031759Class IIAcon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug Multi-Line Drug Screen Test CardACON Laboratories, Inc. / cleared 2003-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)