23
Apr
2003

Misys Healthcare Systems Class III

0

Company: Misys Healthcare Systems
Date of Enforcement Report: 4/23/03
Class: III

PRODUCT
Misys Laboratory_ Blood Bank System computer software (3 versions).
Recall # B-0791-3.

REASON
Blood bank computer software contained a defect that could result in the incomplete displaying of red blood cell antigen and antibody information for a unit of blood.

CODE
Version numbers 5.2, 5.23, and 5.3.

RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by facsimile on January 10, 2003. Firm initiated recall is Complete.

VOLUME OF PRODUCT IN COMMERCE
3 versions.

DISTRIBUTION
Nationwide, United Kingdom, Ireland, Canada, Bermuda, and Saudi Arabia.

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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