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
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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/ Manufacturer |
Bio-Rad Laboratories Inc 4000 Alfred Nobel Dr Hercules CA 94547-1803
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For Additional Information Contact | 510-724-7000 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = LKJ
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