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U.S. Department of Health and Human Services

Class 3 Device Recall BioRad Laboratories Autoimmune EIA ANA Screening kit, 96 test

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  Class 3 Device Recall BioRad Laboratories Autoimmune EIA ANA Screening kit, 96 test see related information
Date Initiated by Firm June 24, 2010
Date Posted December 13, 2010
Recall Status1 Terminated 3 on August 08, 2011
Recall Number Z-0612-2011
Recall Event ID 56126
510(K)Number K954723  
Product Classification Antinuclear antibody, antigen, control - Product Code LKJ
Product Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.
Code Information Manufactured on 06/07/2010, lot number 24501097
Recalling Firm/
Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact
Manufacturer Reason
for Recall
Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass..
FDA Determined
Cause 2
Labeling mix-ups
Action Bio-Rad issued Medical Device Recall Notification letters dated June 24, 2010 to consignees, identifying the affected products and requested that all affected product be disposed of in accordance with local procedures. Response forms are to be completed and returned to the firm. Bio-Rad can be contacted for replacement product and about this recall at 510 741-6114.
Quantity in Commerce 37 units
Distribution Nationwide Distribution: including the states of California, Ohio, Massachusetts, and Missouri. Product delivered to 11 consignees only in the US.
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 = LKJ and Original Applicant = HELIX DIAGNOSTICS, INC.