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U.S. Department of Health and Human Services

Class 2 Device Recall Quest EIA ANA Screen Bulk Kit

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  Class 2 Device Recall Quest EIA ANA Screen Bulk Kit see related information
Date Initiated by Firm February 26, 2010
Date Posted December 13, 2010
Recall Status1 Terminated 3 on January 05, 2011
Recall Number Z-0608-2011
Recall Event ID 55815
Product Classification Antinuclear antibody, antigen, control - Product Code LKJ
Product Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. For labeling and distribution by Quest International Inc.
Medical device is used as a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA), histones, SS-A/Ro, SS-B/LA, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IFA) HEp-2.
Code Information 96AN-Bulk Pack Unlabeled Components (Catalog No. 96 AN-BPU-QUEST) for ANA Screening Test; Lot No. 24591991, 24592395, 24500249, 24500250; Expiration date: 6/2010 (Lot 24952395); 12/2010
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 value for the ANA Cutoff and ANA Positive Controls will decrease overtime resulting in an unusually elevated positivity rate for patient samples tested.
FDA Determined
Cause 2		 Other
Action Bio-Rad Laboratories, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 24, 2010, to their customer. The letter identified the product, the problem, and the action to be taken. The customer was instructed to: Examine inventory and quarantine affected product. Identify all customers that have received the affected product and immediately notify them. Instruct them to discontinue use of the affected product. Complete and return the enclosed MEDICAL DEVICE RECALL RESPONSE FORM. For questions regarding this recall call (510) 724-7000.
Quantity in Commerce 453 kits
Distribution Nationwide Distribution including FL
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.
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