| Class 3 Device Recall BioRad |  |
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 |
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/ Manufacturer |
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 | 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. |
Total Product Life Cycle | TPLC Device Report |
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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.
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