Recall – Blood bank software error

Company: Community Blood Center of the Ozarks
Date of Enforcement Report: 2/10/2021
Class II

PRODUCT

Red Blood Cells, Leukocytes Reduced

Recall Number: B-0216-2021

REASON

Blood products, associated with a blood bank software glitch, were distributed.

RECALLING FIRM/MANUFACTURER

Community Blood Center of the Ozarks on 9/25/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

7 units

DISTRIBUTION

U.S. Nationwide

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.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.