Z-1648-2011

Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 576 Tests, Catalog No. 576DS, Distributed by and...

Name: Z-1648-2011 Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 576 Tests, Catalog No. 576DS, Distributed by and...
Creator: Bio-Rad Laboratories Inc
Published: 2010-03-02
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2010-03-02 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories Inc began a recall of 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... on 2010-03-02. The reason FDA records is "The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1648-2011
Status: Terminated
Initiated: 2010-03-02
Posted: 2011-03-14
Terminated: 2011-03-15
Recalling firm: Bio-Rad Laboratories Inc.
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.
Product code: LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Reason for recall: The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: Lot Numbers: 23192011, exp. 10/31/2010 23192043, exp. 12/31/2010 23192491 exp 3/31/2011 23191837 exp. 7/31/2010

Product code LRM

K960091Class IIEnzyme Immunoassay Anti-Double Stranded DNA (Dsdna) Test KitHelix Diagnostics, Inc. / cleared 1996-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)