May

2008

Inc, Cl II Beckman Coulter

Company: Beckman Coulter, Inc
Date of Enforcement Report 5/7/2008
Class:lll

PRODUCT
a) Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software
Version 2.1, Automated differential cell counter, Part Number: 626554,
Recall # Z-0958-2008;
b) Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software
Version 2.2, Automated differential cell counter, Part Number 626553,
Recall # Z-0959-2008

REASON
Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data..

RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter on June 29, 2007.
Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
516 units nationwide; 73 units in Canada

DISTRIBUTION
Nationwide and Canada

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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Inc, Cl II Beckman Coulter

Amy Sellers

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