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U.S. Department of Health and Human Services

Class 2 Device Recall EIA AntidsDNA Test Kit

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  Class 2 Device Recall EIA AntidsDNA Test Kit see related information
Date Initiated by Firm March 02, 2010
Date Posted March 14, 2011
Recall Status1 Terminated 3 on March 15, 2011
Recall Number Z-1648-2011
Recall Event ID 56044
510(K)Number K960091  
Product Classification Anti-dna antibody (enzyme-labeled), antigen, control - Product Code LRM
Product Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 576 Tests,
Catalog No. 576DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA

The Bio-Rad Autoimmune EIA Anti-dsDNA Test is a qualitative enzyme immunoassay (EIA) intended to screen for the presence of dsDNA antibodies in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE). For In Vitro Diagnostic Use.

Code Information Lot Numbers: 23192011, exp. 10/31/2010 23192043, exp. 12/31/2010 23192491 exp 3/31/2011 23191837 exp. 7/31/2010  
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact Jolene Bartilson
510-724-6114
Manufacturer Reason
for Recall		 The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, Bio-Rad, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated March 2, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and quarantine the affected kit lots; discard all affected product in accordance with all local, state and federal disposal procedures; complete and return the enclosed MEDICAL DEVICE RECALL RESPONSE FORM via fax to: (510) 741-3954, attn: Bio-Rad CSD Regulatory Affairs Department, and to please re-evaluate all positive patient samples and retest if necessary. If you have any questions, contact Bio-Rad CSD Regulatory Affairs Department at 510-724-7000.
Distribution Worldwide distribution: USA and countries including: Canada, Carribean, Chile, France, Germany, Hong Kong, India, Italy, Japan, New Zealand, Panama, Singapore, South Korea and United Kingdom.
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 = LRM and Original Applicant = HELIX DIAGNOSTICS, INC.
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