Z-0612-2011

Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by...

Name: Z-0612-2011 Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by...
Creator: Bio-Rad Laboratories Inc
Published: 2010-06-24
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2010-06-24 / Terminated / root cause: labeling and UDI

FDA source

Bio-Rad Laboratories Inc began a recall of Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc on 2010-06-24. The reason FDA records is "Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0612-2011
Status: Terminated
Initiated: 2010-06-24
Posted: 2010-12-13
Terminated: 2011-08-08
Recalling firm: Bio-Rad Laboratories Inc.
Product: Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.
Product code: LKJ Antinuclear Antibody, Antigen, Control
Reason for recall: Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass..
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Bio-Rad issued Medical Device Recall Notification letters dated June 24, 2010 to consignees, identifying the affected products and requested that all affected product be disposed of in accordance with local procedures. Response forms are to be completed and returned to the firm. Bio-Rad can be contacted for replacement product and about this recall at 510 741-6114.
Quantity in commerce: 37 units
Distribution: Nationwide Distribution: including the states of California, Ohio, Massachusetts, and Missouri. Product delivered to 11 consignees only in the US.
Product codes and lots: Manufactured on 06/07/2010, lot number 24501097

Product code LKJ

K954723Class IIEnzyme Immunoassay Ana Screening Test KitHelix Diagnostics, Inc. / cleared 1995-12-15

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)