Blood Bank Control System (BBCS) Cl II

Company: Blood Bank Computer Systems, Inc
Date of Enforcement Report 1/25/2017
Class lI:

PRODUCT

Blood Bank Control System (BBCS) Primary Application, V 5.4.3, 5.5 is intended to address all phases of donor and transfusion services. The software is also capable of operating with or without ABO QuickPass (BK14130) to allow donors to complete Computer Assisted Self Interviews (CASI) and computer assisted blood donor registrations..
Recall Number B-0257-2017

REASON
Blood Bank Control System (BBCS) with Primary Application (software version BBCS Primary Application 5.4.3, 5.5; ABO Express 1.0.0, 1.1.0, 1.2.0), with a defect or glitch, was distributed.

RECALLING FIRM/MANUFACTURER
Blood Bank Computer Systems, Inc., Auburn, WA on 10/282016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
40 units

DISTRIBUTION
Nationwide

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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