Aug

2011

Cl ll Blood Bank Computer Service (BBCS)

Company: Blood Bank Computer Systems, Inc.
Date of Enforcement Report 8/17/11
Class ll:

PRODUCT
Blood Bank Computer Service (BBCS) Mobile Application (versions) 5.0M, 5.1M, and 5.1.1M. The device is a software application used by blood banking firms to track donor information at remote sites to eventually link up with the Primary Application that is linked to the interactive database. Each customer has received three CDs due to software updates, and each CD containing different Serial number. The software CD is labeled in parts: “Blood Bank Control System (Primary Application) Release 5.3.8. Recall # B-1872-11

REASON
(BBCS) Mobile Application (versions) 5.0M, 5.1M, and 5.1.1M, with a software glitch or defect, were distributed.

RECALLING FIRM/MANUFACTURER
Blood Bank Computer Systems, Inc., Auburn, WA, by e-mail dated September 13, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
102 CDs

DISTRIBUTION
Nationwide

About the author

Amy Sellers

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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Cl ll Blood Bank Computer Service (BBCS)

Amy Sellers

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