20
Apr
2005

Inc Class III Diasorin

0

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.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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