Z-0673-05

Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of...

Name: Z-0673-05 Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of...
Creator: Diasorin Inc.
Published: 2004-04-12
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2004-04-12 / Terminated

FDA source

Diasorin Inc. began a recall of Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit on 2004-04-12. The reason FDA records is "The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0673-05
Status: Terminated
Initiated: 2004-04-12
Posted: 2005-04-06
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
Product: Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit
Product code: DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Reason for recall: The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.
FDA root cause: Other
Action: A notification letter and effectiveness check form was sent to consignees. This letter recommended that users manually verify results using the specifications outlined in the package insert until a new software version is installed.
Quantity in commerce: 8
Distribution: CA, CT, KS, MA & WA
Product codes and lots: Software version 12

Product code DBM

K921183Class IIDiastat Anti-Mitochondrial Antibody KitShield Diagnostics, Ltd. / cleared 1992-06-19

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)