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Terminated

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

FDA Recall Z-0676-05 · Posted 2005-04-06

Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeDHN
Date Initiated2004-06-30
Date Terminated2006-07-22
Product Quantity14

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.

Firm 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.

Root Cause

Other

Distribution Pattern

AL, AZ, CA, CO, FL, KY, MO, NC, NJ, NV, OH, TX, & VA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K822397ANA HEP-2 FLUORO-KITClinical Sciences, Inc. · 1982-09-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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