Recall – Blood products collected during software error distributed

Company: Mississippi Valley Reg Bld Ctr
Date of Enforcement Report: 8/7/2019
Class II

PRODUCT

Red Blood Cells, Leukocytes Reduced

  • Recall Number: B-0768-2019

Platelets

  • Recall Number: B-0769-2019

REASON

Blood products, collected during a software error with blood mixers, were distributed.

RECALLING FIRM/MANUFACTURER

Mississippi Valley Reg Bld Ctr on 8/7/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
8 units

DISTRIBUTION

US Nationwide

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. 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) and Italy.