Recall Z-0807-05 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Diasorin Inc.
Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test.
| Date | May 10, 2005 (initiated Sep 24, 2004) |
| Status | Terminated |
| Reason | 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 | 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 | 13 |
| Distribution | OH, NJ, KY, TX, NC, FL, VA, WA, AL, CO, MO, AZ , CA , CT & NV |
| 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 |