Inc. Class II Beckman Coulter

Company:Beckman Coulter, Inc
Date of Enforcement Report: 11/6/02
Class: II

PRODUCT
Synchron LX 20, Part # 466101;
Synchron LX 20 Pro, Part # 466200. Recall # Z-0150-3.

REASON
Low results on the cartridge chemistry assays, syringe valve seat issue.

CODE
All units with software version 2.1 are affected.

RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter in February 2002. Firm
initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
793.

DISTRIBUTION
Nationwide and Canada.

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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