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U.S. Department of Health and Human Services

Class 2 Device Recall BioRad brand Meridian ANA Screen ELISA Test Kit

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  Class 2 Device Recall BioRad brand Meridian ANA Screen ELISA Test Kit see related information
Date Initiated by Firm February 24, 2010
Date Posted December 13, 2010
Recall Status1 Terminated 3 on January 10, 2011
Recall Number Z-0613-2011
Recall Event ID 56386
510(K)Number K954723  
Product Classification Antinuclear antibody, antigen, control - Product Code LKJ
Product Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test,
Catalog No. 4884261, Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Meridian Diagnostics.
Code Information Lot Numbers:   24591982, 24591999, 24592673, 24592393  
Recalling Firm/
Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact
Manufacturer Reason
for Recall
False positive test results caused by decrease in the OD values of ANA Cutoff Controls and ANA Positive Controls. The increased positivity rates were associated with the Meridian ANA Screening kit. False positive ANA values could result in misdiagnosis or mistreatment .
FDA Determined
Cause 2
Action Bio-Rad issued an Urgent Medical Device Recall NOtification letter dated February 24, 2010 to their distributor, identifying the affected product and actions to be taken. The distributor was instructed to examine inventory and quarantive affected kit lots, and to identify and notify customers with affected lots to discontinue use and discard the product. Replacement kits will be distributed. Customers were asked to complete and return a recall response form. Bio-Rad can be contacted at 510 724-7000 concerning this recall.
Distribution Nationwide Distribution: to Meridian Diagnostics in Ohio.
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.