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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

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