Recall Z-1648-2011 ยท LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Bio-Rad Laboratories Inc
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 Diagnost
| Date | Mar 14, 2011 (initiated Mar 2, 2010) |
| Status | Terminated |
| Reason | The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits. |
| Root cause | 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960091 | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT Helix Diagnostics, Inc., Mar 20, 1996 |