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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/See see related information
Date Initiated by Firm February 12, 2007
Date Posted April 10, 2007
Recall Status1 Terminated 3 on February 04, 2008
Recall Number Z-0733-2007
Recall Event ID 37465
510(K)Number K031759  
Product Classification Drug Screen (urine) - Product Code DKZ
Product Bio-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
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.
Quantity in Commerce 177 Kits
Distribution Worldwide distribution --- USA and countries of Australia 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.
510(K) Database 510(K)s with Product Code = DKZ and Original Applicant = ACON LABORATORIES, INC.
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