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U.S. Department of Health and Human Services

Class 2 Device Recall Autoimmune EIA ANA Screening Test Kit Model 96AN

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  Class 2 Device Recall Autoimmune EIA ANA Screening Test Kit Model 96AN see related information
Date Initiated by Firm March 01, 2010
Date Posted December 06, 2010
Recall Status1 Terminated 3 on January 05, 2011
Recall Number Z-0539-2011
Recall Event ID 56047
510(K)Number K954723  
Product Classification Antinuclear antibody, antigen, control - Product Code LKJ
Product Autoimmune EIA ANA Screening Test Kit, 96 Tests,
Model/Catalog Number: 96AN manufactured by Bio-Rad, Hercules, CA
Code Information Lot Numbers: 24591573,  24591983,  24592004,  24592036,  24592098,  24592377,  24592455,  24500033,  24500216   
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact
510-724-7000
Manufacturer Reason
for Recall		 The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.
FDA Determined
Cause 2		 Other
Action Bio-Rad issued an Urgent Medical Device Recall Notification letter dated March 1, 2010 to customers describing the issue and actions to be taken. Responses will be tracked via response forms. The letter instructed customers that affected products should be identified, quarantined, and discarded, or reworked with shorter expiration dates until newer lots are available. Bio-Rad can be contacted at 510-724-7000 concerning this recall.
Distribution Worldwide Distribution: Throughout the US, and to the countries of: Australia, Canada, France, Hong Kong, India, Italy, Japan, New Zealand, Panama, Singapore, South Korea and the UK.
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.
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