Z-0676-05

PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System...

Name: Z-0676-05 PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System...
Creator: Diasorin Inc.
Published: 2004-06-30
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2004-06-30 / Terminated / root cause: manufacturing process

FDA source

Diasorin Inc. began a recall of PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin... on 2004-06-30. The reason FDA records is "The program for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160". 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-0676-05
Status: Terminated
Initiated: 2004-06-30
Posted: 2005-04-06
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
Product: PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluroescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604
Product code: DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Reason for recall: The program for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160.
Root cause tag: manufacturing process
FDA root cause: Other
Action: All customers were notified of the problem via phone and letter. Verbal instructions were given of how to change the Calibrator 2 titer to the correct one. A letter instructs customer to return software disc to DiaSorin, remove version 2.8 from the computer and install version 2.8.1.
Quantity in commerce: 14
Distribution: AL, AZ, CA, CO, FL, KY, MO, NC, NJ, NV, OH, TX, & VA
Product codes and lots: polyTiter software version 2.8

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)