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

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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