Inc. Class III Diasorin

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

PRODUCT
Data reduction program software written specifically for Bio-Tek Elx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700). Recall # Z-0675-05.

REASON
The data reduction program written for a specific automated microtiter plate reader (Bio-Tek Elx800) was found to be faulty. This program is used to calculate the cut off values for the Diastat Anti-Thyroglobulin Kit assay. The negative Control Upper Limit should be less than 0.95, rather than less than 1.0.

CODE
Software version 9 thru 12.

RECALLING FIRM/MANUFACTURER
Diasorin, Inc., Stillwater, MN, by letter on April 12, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
6.

DISTRIBUTION
CA, FL, MA, NY, and TX.

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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