Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 96 Tests, Catalog No. 96DS, 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.
- Company
- Bio-Rad Laboratories Inc
- Recall Initiated
- March 2, 2010
- Posted
- March 14, 2011
- Terminated
- March 15, 2011
- Recall Number
- Z-1647-2011
- Firm Location
- Hercules, CA
Reason for Recall
The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits.
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.
Lot / Code Info
Lot Numbers: 23191977, exp. 10/31/2010 23191979, exp. 10/31/2010 23191990, exp. 10/31/2010 23192172, exp. 10/31/2010 23192174, exp. 10/31/2010 23192175, exp. 12/31/2010 23192176, exp. 12/31/2010 23192490, exp. 2/28/2011 23100007, exp. 2/28/2011 23191837,
Root Cause
Nonconforming Material/Component
Action Taken
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.