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Terminated

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

FDA Recall Z-0289-06 · Posted 2005-12-15

Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeDIO
Date Initiated2004-06-04
Date Terminated2006-04-14
Product Quantity384 units

Reason for Recall

The device was producing false negative results for cocaine tests.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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