Inc Class III Mediware Information Systems

Company: Mediware Information Systems, Inc
Date of Enforcement Report: 1/23/02
Class: III

PRODUCT
Hemocare Blood Bank Data Management System, Recall # B-0666-2.

REASON
Defects in the design of blood bank software programs could result in the release of unsuitable blood products.

CODE
Version 5.1, 5.2 and/or 5.2a.

RECALLING FIRM/MANUFACTURER
Mediware Information Systems, Inc., Melville, NY, by letter on Sept. 18, 2000. Firm initiated recall ongoing.

VOLUME OF PRODUCT IN COMMERCE
273 distributed.

DISTRIBUTION
Nationwide and Internationally

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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