Inc Class II Beckman Coulter

Company: Beckman Coulter, Inc
Date of Enforcement Report: 8/24/05
Class: II

PRODUCT
Cytomics FC500 MPL with MXP Software, Recall # Z-1377-05

REASON
Software anomaly. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results.

CODE
Versions 1.1 and 2.0

RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letters on July 13, 2005.
Manufacturer: Applied Cytometry Systems, Dinnington, UK. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
36 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.

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