17
Apr
2013

Cl ll Blood bank software Primary Application

,
0

Company:Blood Bank Computer Systems, Inc .
Date of Enforcement Report 4/17/2013
Class ll:

PRODUCT

Blood bank software Primary Application with Model numbers 5.4.0; 5.4.0.1; 5.4.0.2; and 5.4.1 Recall Number B-1345-13

REASON
Blood Bank Software, with a defect or glitch, was distributed.

RECALLING FIRM/MANUFACTURER
Blood Bank Computer Systems, Inc, Auburn, WA, on 12/5/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4

DISTRIBUTION
Nationwide

___________________________________

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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