FDA Recall Terminated

Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA

Recall: Z-0733-2007 · Initiated February 12, 2007

Recall

Recall Number
Z-0733-2007
Event Number
37465
Firm
Bio-Rad Laboratories Inc
FEI Number
2915274
Product Code
DKZ
Status
Terminated
Root Cause
Other
Initiated
February 12, 2007
Posted
April 10, 2007
Terminated
February 4, 2008
Address
4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

Description

Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA

Reason

The product may produce a faint line which could be interpreted as a false negative test result .

Action

The firm intends to contact its subsidiary distributors and sales staff via Fax (Feb 12, 2007) and phone call. In addition, the recall notification will be posted on the firm's intranet site. Customers are instructed to destroy recalled product following standard laboratory practices.

Distribution

Worldwide distribution --- USA and countries of Australia and Italy.

Quantity

177 Kits