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U.S. Department of Health and Human Services

Class 2 Device Recall Autoimmune EIA ANA Screening Kit

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  Class 2 Device Recall Autoimmune EIA ANA Screening Kit see related information
Date Initiated by Firm March 01, 2010
Date Posted March 02, 2011
Recall Status1 Terminated 3 on March 11, 2011
Recall Number Z-1479-2011
Recall Event ID 56385
510(K)Number K954723  
Product Classification Antinuclear Antibody, Antigen Control - Product Code LKJ
Product Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests,
Catalog No. 96AN-BPU-TRINITY. Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Trinity Biotech, USA.

Intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases.

Code Information Lot Numbers: 24591524, exp 10/31/2010; 24591936, exp 12/31/2010; and 24500022, exp 12/31/2010.  
Recalling Firm/
Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact
Manufacturer Reason
for Recall
The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability.
FDA Determined
Cause 2
Nonconforming Material/Component
Action An Urgent: Medical Device Recall Notification, dated March 1, 2010, was provided to the firm's consignee, identifying the affected product and stating the reason for the recall. The letter also asked the customer to examine their inventory and quarantine the affected kits. If the product had been further distributed, those customers must be identified, notified, and asked to discontinue use of the affected product. Customers were to discard all affected product and complete and return the enclosed Medical Device Recall Response Form. The letter also stated that replacement kits would be available in mid-March.
Quantity in Commerce 2,109 bulk packs
Distribution Nationwide Distribution -- New York, 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.