Aug

2008

Cl Il Cytomics FC 500 Flow Cytometry System

Company: Beckman Coulter Inc
Date of Enforcement Report 8/13/2008
Class:ll

PRODUCT
Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles, Recall # Z-1529-2008

REASON
Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated August 16, 2007.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
141 units

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 Il Cytomics FC 500 Flow Cytometry System

Amy Sellers

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