Class 3 Device Recall BioRad

• Date Initiated by Firm: June 04, 2004
• Date Posted: December 15, 2005
• Recall Status: Terminated 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/ 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: 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

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.