Cerner Corporation Class II

Company: Cerner Corporation
Date of Enforcement Report: 5/4/05
Class: II

PRODUCT
HNA Classic 306 Patient Manager Blood Bank Software. Recall # B-0843-5.

REASON
Defects in the design of blood bank software could result in loss of patient antibody information.

CODE
Revision 159 and higher.

RECALLING FIRM/MANUFACTURER
Cerner Corporation, Kansas City, MO, by telephone calls beginning on 2/25/05, and completed by March 1, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
246 software packages.

DISTRIBUTION
Nationwide and Internationally.

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.

Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.