Apr

2005

Inc Class III Diasorin

Company: Diasorin, Inc
Date of Enforcement Report: 4/20/05
Class: III

PRODUCT
Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit. Recall # Z-0674-05.

REASON
The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml.

CODE
Software version 12.

RECALLING FIRM/MANUFACTURER
Diasorin, Inc., Stillwater, MN, by letter on October 26, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7.

DISTRIBUTION
CT, MI, MT, UT, and Canada.

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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Inc Class III Diasorin

Amy Sellers

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