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U.S. Department of Health and Human Services

Class 3 Device Recall RELISA ENA Multiparameter Antibody Screening test

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 Class 3 Device Recall RELISA ENA Multiparameter Antibody Screening testsee related information
Date Initiated by FirmNovember 25, 2008
Date PostedApril 06, 2009
Recall Status1 Terminated 3 on November 17, 2009
Recall NumberZ-1045-2009
Recall Event ID 50519
510(K)NumberK935129 
Product Classification Extractable antinuclear antibody, antigen and control - Product Code LLL
ProductRELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.
Code Information Kit Catalog Number 7096-09, Lot Number 0821407 and Kit Catalog Number 7696-09, Lot Number 0821404.
Recalling Firm/
Manufacturer		 Immuno Concepts Inc
9779 Business Park Dr Ste D
Sacramento CA 95827-1715
For Additional Information Contact
916-363-2649
Manufacturer Reason
for Recall		In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.
FDA Determined
Cause 2		Process control
ActionThe firm has issued telephone calls, e-mails and notification letters to its consignees.
Quantity in Commerce25 kits
DistributionWorldwide Distribution including USA, Australia, England, Sweden and Austria.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLL
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