Z-0539-2011

Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured by Bio-Rad...

Name: Z-0539-2011 Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured by Bio-Rad...
Creator: Bio-Rad Laboratories Inc
Published: 2010-03-01
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2010-03-01 / Terminated

FDA source

Bio-Rad Laboratories Inc began a recall of Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured by Bio-Rad, Hercules, CA on 2010-03-01. The reason FDA records is "The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0539-2011
Status: Terminated
Initiated: 2010-03-01
Posted: 2010-12-06
Terminated: 2011-01-05
Recalling firm: Bio-Rad Laboratories Inc.
Product: Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured by Bio-Rad, Hercules, CA
Product code: LKJ Antinuclear Antibody, Antigen, Control
Reason for recall: The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.
FDA root cause: Other
Action: Bio-Rad issued an Urgent Medical Device Recall Notification letter dated March 1, 2010 to customers describing the issue and actions to be taken. Responses will be tracked via response forms. The letter instructed customers that affected products should be identified, quarantined, and discarded, or reworked with shorter expiration dates until newer lots are available. Bio-Rad can be contacted at 510-724-7000 concerning this recall.
Distribution: Worldwide Distribution: Throughout the US, and to the countries of: Australia, Canada, France, Hong Kong, India, Italy, Japan, New Zealand, Panama, Singapore, South Korea and the UK.
Product codes and lots: Lot Numbers: 24591573, 24591983, 24592004, 24592036, 24592098, 24592377, 24592455, 24500033, 24500216

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)