Z-0608-2011

Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc...

Name: Z-0608-2011 Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc...
Creator: Bio-Rad Laboratories Inc
Published: 2010-02-26
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2010-02-26 / Terminated

FDA source

Bio-Rad Laboratories Inc began a recall of Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. For labeling and distribution by Quest... on 2010-02-26. The reason FDA records is "The value for the ANA Cutoff and ANA Positive Controls will decrease overtime resulting in an unusually elevated positivity rate for patient samples tested". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0608-2011
Status: Terminated
Initiated: 2010-02-26
Posted: 2010-12-13
Terminated: 2011-01-05
Recalling firm: Bio-Rad Laboratories Inc.
Product: Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. For labeling and distribution by Quest International Inc. Medical device is used as a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA), histones, SS-A/Ro, SS-B/LA, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IFA) HEp-2.
Product code: LKJ Antinuclear Antibody, Antigen, Control
Reason for recall: The value for the ANA Cutoff and ANA Positive Controls will decrease overtime resulting in an unusually elevated positivity rate for patient samples tested.
FDA root cause: Other
Action: Bio-Rad Laboratories, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 24, 2010, to their customer. The letter identified the product, the problem, and the action to be taken. The customer was instructed to: Examine inventory and quarantine affected product. Identify all customers that have received the affected product and immediately notify them. Instruct them to discontinue use of the affected product. Complete and return the enclosed MEDICAL DEVICE RECALL RESPONSE FORM. For questions regarding this recall call (510) 724-7000.
Quantity in commerce: 453 kits
Distribution: Nationwide Distribution including FL
Product codes and lots: 96AN-Bulk Pack Unlabeled Components (Catalog No. 96 AN-BPU-QUEST) for ANA Screening Test; Lot No. 24591991, 24592395, 24500249, 24500250; Expiration date: 6/2010 (Lot 24952395); 12/2010

Product code LKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)