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
- Company
- Diasorin Inc.
- Recall Initiated
- June 30, 2004
- Posted
- April 6, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0676-05
- Quantity
- 14
- Firm Location
- Stillwater, MN
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.
Distribution
AL, AZ, CA, CO, FL, KY, MO, NC, NJ, NV, OH, TX, & VA
Lot / Code Info
polyTiter software version 2.8
Root Cause
Other
Action Taken
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.
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