Company: Diasorin, Inc
Date of Enforcement Report: 4/20/05
Class: III
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 fluorescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604. Recall # Z-0676-05.
REASON
The program is 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.
CODE
PolyTiter software version 2.8.
RECALLING FIRM/MANUFACTURER
Diasorin, Inc., Stillwater, MN, by telephone and letter on June 30, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
14.
DISTRIBUTION
Nationwide.
