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 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) and Italy.