Z-0289-06

Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216, 194-5223

Name: Z-0289-06 Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216, 194-5223
Creator: Bio-Rad Laboratories Inc
Published: 2004-06-04
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2004-06-04 / Terminated

FDA source

Bio-Rad Laboratories Inc began a recall of Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216, 194-5223 on 2004-06-04. The reason FDA records is "The device was producing false negative results for cocaine tests". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0289-06
Status: Terminated
Initiated: 2004-06-04
Posted: 2005-12-15
Terminated: 2006-04-14
Recalling firm: Bio-Rad Laboratories Inc.
Product: Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216, 194-5223
Product code: DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Reason for recall: The device was producing false negative results for cocaine tests.
FDA 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 in commerce: 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.
Product codes and lots: 9450311-1, 9450319, 9450545, 9450547, 9450311, 9451356, 94532016CE

Product code DIO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)