28
Aug
2002

Diasorin Inc Class II

0

Company: Diasorin Inc
Date of Enforcement Report: 8/28/02
Class: II

PRODUCT
Medusa software, DiaSorin Part 15794, for an OMNI (automated microtiter plate) Instrument used for the ETI-HA-IGMK Plus Enzyme Immunoasay for the Detection of IgM Antibody to Hepatitis A Virus in Human Serum or Plasma.
Recall # Z-1265-2.

REASON
As a result of a software error, the cut-off for the ETI-HA-IGMK Plus kit would be incorrectly calculated, potentially causing false negative results to be reported.

CODE
Medusa software, DiaSorin Part 15794.

RECALLING FIRM/MANUFACTURER
Diasorin Inc., Stillwater, MN, by telephone on June 11 and 12, 2002.
Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
Six laboratories had the defective software.

DISTRIBUTION
FL, KS, 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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