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U.S. Department of Health and Human Services

Class 3 Device Recall BioRad

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  Class 3 Device Recall BioRad see related information
Date Initiated by Firm June 04, 2004
Date Posted December 15, 2005
Recall Status1 Terminated 3 on April 14, 2006
Recall Number Z-0289-06
Recall Event ID 34055
510(K)Number K003160  
Product Classification Enzyme Immunoassay, Cocaine And Cocaine Metabolites - Product Code DIO
Product Bio-Rad brand ''TOX/See Drug Screen Test'';

Catalog numbers: 1945182EX, 1945216, 194-5223
Code Information 9450311-1, 9450319, 9450545, 9450547, 9450311, 9451356,   94532016CE
Recalling Firm/
Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
Manufacturer Reason
for Recall
The device was producing false negative results for cocaine tests.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.