Z-0807-05

Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with...

Name: Z-0807-05 Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with...
Creator: Diasorin Inc.
Published: 2004-09-24
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2004-09-24 / Terminated / root cause: software

FDA source

Diasorin Inc. began a recall of Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody... on 2004-09-24. The reason FDA records is "A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (including values changed to unacceptable...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0807-05
Status: Terminated
Initiated: 2004-09-24
Posted: 2005-05-10
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
Product: Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test.
Product code: DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Reason for recall: A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the 'refresh button' has not been pressed. The graph may appear valid; however erroneous results may occur.
Root cause tag: software
FDA root cause: Other
Action: Customers were sent a Technical Bulletin describing the correct procedure to be used when entering data into the Poly/Titer tiration system, until the updated software is installed
Quantity in commerce: 13
Distribution: OH, NJ, KY, TX, NC, FL, VA, WA, AL, CO, MO, AZ , CA , CT & NV
Product codes and lots: all versions of software

Product code DHN

K822397Class IIAna Hep-2 Fluoro-KitClinical Sciences, Inc. / cleared 1982-09-21

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)