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U.S. Department of Health and Human Services

Class 2 Device Recall BioRad TOX/See

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 Class 2 Device Recall BioRad TOX/Seesee related information
Date Initiated by FirmFebruary 12, 2007
Date PostedApril 10, 2007
Recall Status1 Terminated 3 on February 04, 2008
Recall NumberZ-0733-2007
Recall Event ID 37465
510(K)NumberK031759 
Product Classification Drug Screen (urine) - Product Code DKZ
ProductBio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA
Code Information DOA6120272
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
Manufacturer Reason
for Recall		The product may produce a faint line which could be interpreted as a false negative test result .
FDA Determined
Cause 2		Other
ActionThe 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.
Quantity in Commerce177 Kits
DistributionWorldwide distribution --- USA and countries of Australia and Italy.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = DKZ
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