25
Jan
2006

Class II Beckman Coulter Inc

0

Company: Beckman Coulter Inc.
Date of Enforcement Report:1/25/2006
Class:II

PRODUCT
Cytomics FC500 Cytometer with CXP Software, Part Numbers 629636 629637, Recall # Z-0380-06

REASON
Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0.

CODE
CXP Cytometer Software Version 2.0 (acquisition software only).

RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc, Brea, CA, by letter on November 28, 2005.
Manufacturer: Applied Cytometry Systems, Dinnington, United Kingdom. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
179

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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