Z-1478-2011

DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories

Name: Z-1478-2011 DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories
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 DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories on 2010-03-01. The reason FDA records is "Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit". 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-1478-2011
Status: Terminated
Initiated: 2010-03-01
Posted: 2011-03-02
Terminated: 2011-03-11
Recalling firm: Bio-Rad Laboratories Inc.
Product: DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.
Product code: LKJ Antinuclear Antibody, Antigen, Control
Reason for recall: Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Recall was initiated on 3/1/2010. DiaSorin S.R.I. (the sole consignee) was alerted via email using the firm's Medical Device Recall Notification. Consignee informed of the recall and instructed to dispose of the affected product according to local laws.
Quantity in commerce: 999 kits
Distribution: Foreign Only: One distributor, DiaSorin S.R.I. in Italy. No wholesalers. No retailers. No domestic distribution, No Federal Government sales/distribution centers.
Product codes and lots: Model number N0093, manufacture dates 09/17/2009 and 10/12/2009, lot numbers 24592003and 24592035.

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)