30
Jan
2002

Inc Class III Mediware Information Systems

0

Company: Mediware Information Systems, Inc
Date of Enforcement Report: 2/30/02
Class: III

PRODUCT
Hemocare Blood Bank Data Management System Software, Recall # B-0626-2.

REASON

Computer software that could allow the assignment of an extended expiration date to blood products was distributed.

CODE
Versions 5.1, 5.2, 5.2a, and 5.2b.

RECALLING FIRM/MANUFACTURER
Mediware Information Systems, Inc., Melville, NY by fax and letter on May 29, 2001. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
4 versions.

DISTRIBUTION
Nationwide and Canada.

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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Instructor: Dr Peter Rech, 2nd instructor (optional)

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