18
Dec
2002

Inc Class III Mediware Information Systems

0

Company: Mediware Information Systems, Inc
Date of Enforcement Report: 12/18/02
Class: III

PRODUCT
Hemacare Blood Bank Data Management System,
Recall # B-0301-3 REASON
Blood bank computer software, which had a defect that could cause antigen test results to be associated with the wrong unit or sample, was distributed.

CODE
Version 5.2b(b).

RECALLING FIRM/MANUFACTURER
Mediware Information Systems, Inc., Melville, NY, by letter dated June 25, 2002. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1 version.

DISTRIBUTION
Nationwide, Singapore 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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