Inc Class II Beckman Coulter

Company: Beckman Coulter, Inc
Date of Enforcement Report: 6/23/04
Class: II

PRODUCT
DL 2000 Data Manager. Recall # Z-1027-04.

REASON
Software defect. The type of results affected were replicate type results for a single sample transmitted within the same data stream.

CODE
Version 6.2.

RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letters on February 14, 2003. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
231 units.

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.

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.