Z-0613-2011

Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261, Manufactured by: Bio-Rad...

Name: Z-0613-2011 Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261, Manufactured by: Bio-Rad...
Creator: Bio-Rad Laboratories Inc
Published: 2010-02-24
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2010-02-24 / Terminated

FDA source

Bio-Rad Laboratories Inc began a recall of Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261, Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by... on 2010-02-24. The reason FDA records is "False positive test results caused by decrease in the OD values of ANA Cutoff Controls and ANA Positive Controls. The increased positivity rates were associated with the Meridian ANA Screening kit. False positive ANA...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0613-2011
Status: Terminated
Initiated: 2010-02-24
Posted: 2010-12-13
Terminated: 2011-01-10
Recalling firm: Bio-Rad Laboratories Inc.
Product: Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261, Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Meridian Diagnostics.
Product code: LKJ Antinuclear Antibody, Antigen, Control
Reason for recall: False positive test results caused by decrease in the OD values of ANA Cutoff Controls and ANA Positive Controls. The increased positivity rates were associated with the Meridian ANA Screening kit. False positive ANA values could result in misdiagnosis or mistreatment .
FDA root cause: Other
Action: Bio-Rad issued an Urgent Medical Device Recall NOtification letter dated February 24, 2010 to their distributor, identifying the affected product and actions to be taken. The distributor was instructed to examine inventory and quarantive affected kit lots, and to identify and notify customers with affected lots to discontinue use and discard the product. Replacement kits will be distributed. Customers were asked to complete and return a recall response form. Bio-Rad can be contacted at 510 724-7000 concerning this recall.
Distribution: Nationwide Distribution: to Meridian Diagnostics in Ohio.
Product codes and lots: Lot Numbers: 24591982, 24591999, 24592673, 24592393

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