Recall Z-0676-05 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Diasorin Inc.
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
| Date | Apr 6, 2005 (initiated Jun 30, 2004) |
| Status | Terminated |
| Reason | 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 | 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 | 14 |
| Distribution | AL, AZ, CA, CO, FL, KY, MO, NC, NJ, NV, OH, TX, & VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K822397 | ANA HEP-2 FLUORO-KIT Clinical Sciences, Inc., Sep 21, 1982 |