Z-1479-2011

Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY. Manufactured by...

Name: Z-1479-2011 Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY. Manufactured by...
Creator: Bio-Rad Laboratories Inc
Published: 2010-03-01
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2010-03-01 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories Inc began a recall of Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY. Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and... on 2010-03-01. The reason FDA records is "The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability". 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-1479-2011
Status: Terminated
Initiated: 2010-03-01
Posted: 2011-03-02
Terminated: 2011-03-11
Recalling firm: Bio-Rad Laboratories Inc.
Product: Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY. Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Trinity Biotech, USA. Intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases.
Product code: LKJ Antinuclear Antibody, Antigen, Control
Reason for recall: The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent: Medical Device Recall Notification, dated March 1, 2010, was provided to the firm's consignee, identifying the affected product and stating the reason for the recall. The letter also asked the customer to examine their inventory and quarantine the affected kits. If the product had been further distributed, those customers must be identified, notified, and asked to discontinue use of the affected product. Customers were to discard all affected product and complete and return the enclosed Medical Device Recall Response Form. The letter also stated that replacement kits would be available in mid-March.
Quantity in commerce: 2,109 bulk packs
Distribution: Nationwide Distribution -- New York, US.
Product codes and lots: Lot Numbers: 24591524, exp 10/31/2010; 24591936, exp 12/31/2010; and 24500022, exp 12/31/2010.

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)