Dec

2013

Cl II ElDorado Donor Doc Software

Company: Haemonetics Software Solutions
Date of Enforcement Report:12/11/2013
Class lI:

PRODUCT

ElDorado Donor Doc Software, comprehensive donor health qualification computer system, run in a native Internet Explorer browser that is displayed in kiosk mode. Versions 2.5.0, 2.5.0 (SR1), 2.6.0, 2.6 (SR1), 2.7.0 Recall Number B-0008-14

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

RECALLING FIRM/MANUFACTURER
Haemonetics Software Solutions, El Dorado Hills, CA on 8/22/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
29 of 2.5.0, 30 of 2.5.0 (SR1), 35 of 2.6.0, 34 of 2.6 (SR1), 36 of 2.7.0

DISTRIBUTION
Nationwide and Internationally

___________________________________

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 II ElDorado Donor Doc Software

Amy Sellers

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