May

2005

Diasorin Inc. Class III

Company: Diasorin Inc.
Date of Enforcement Report: 5/18/05
Class: III

PRODUCT
Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin Anafluor Indirect Fluorescent Antibody Test. Recall # Z-0807-05.

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.

CODE
All versions of software.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Diasorin Inc., Stillwater, MN, by letter, on September 24, 2004.
Manufacturer: Polymedco, Inc., Cortlandt Manor, NY. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
68 (27-2.7; 14-2.8 and 27-2.8.1 Software Version).

DISTRIBUTION
Nationwide.

About the author

Amy Sellers

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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Diasorin Inc. Class III

Amy Sellers

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