Inc. Mediware Information Systems

Company: Mediware Information Systems, Inc.
Date: 5/29/01

REASON:
The expiration date of a manufactured product may be mistakenly
extended, without displaying a warning to the user, when
entered under certain specific conditions.

DATE RECALL INITIATED:
May 29, 2001

PRODUCT / VERSIONS
Hemocare Blood Bank Data Management System Software Software versions 5.1, 5.2, 5.2a, 5.2b for use with all QNX4/AIX operating systems

MANUFACTURER:
Mediware Information Systems, Inc.
Melville, New York 11747

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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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