30
Jul
2008

Cytomics FC 500 Flow Cytometry, Cl Il Beckman

0

Company: Beckman Coulter Inc.
Date of Enforcement Report 7/30/2008
Class:ll

PRODUCT
a) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – FC 500 with UPS, Automated differential cell counter; Part
Number: 626553; Recall # Z-2016-2008;
b) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – FC 500 120V, Automated differential cell counter; Part Number
6605628; Recall # Z-2017-2008;
c) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – CXP analysis SW V2.1 single user, Automated differential cell
counter; Part Number 722396; Recall # Z-2018-2008;
d) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – CXP analysis SW V2.1 single user upgrade, Automated differential
cell counter; Part Number 722395; Recall # Z-2019-2008;
e) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – CXP analysis SW V2.1, 3 User Pack, Automated differential cell
counter; Part Number 722397; Recall # Z-2020-2008;
f) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – CXP analysis SW V2.1, 5 User Pack, Automated differential cell
counter; Part Number 722398; Recall # Z-2021-2008;
g) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – CXP analysis SW V2.1, 15 User Pack, Automated differential cell
counter; Part Number 722399; Recall # Z-2022-2008;
h) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – CXP analysis SW V2.1, 5 network user with Romlock, Automated
differential cell counter; Part Number 722593; Recall # Z-2023-2008;
i) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – CXP analysis SW V2.1, 10 network user with Romlock, Automated
differential cell counter; Part Number 722594; Recall # Z-2024-2008;
j) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and
2.2 – CXP analysis SW V2.1, 15 network user with Romlock, Automated
differential cell counter; Part Number 722595; Recall # Z-2025-2008;
k) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – SW Kit, CXP Analyis SW V2.2 Single User, Automated differential
cell counter; Part Number 774197; Recall # Z-2026-2008;
l) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – SW Kit, CXP Analyis SW V2.2 Single User Upgrade, Automated
differential cell counter; Part Number 774198; Recall # Z-2027-2008;
m) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – SW Kit, CXP Analyis SW V2.2, 3 User, Automated differential
cell counter; Part Number 774199; Recall # Z-2028-2008;
n) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – SW Kit, CXP Analyis SW V2.2, 5 User, Automated differential
cell counter; Part Number 774200; Recall # Z-2029-2008;
o) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – SW Kit, CXP Analyis SW V2.2, 15 User, Automated differential
cell counter; Part Number 774201; Recall # Z-2030-2008;
p) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – SW Kit, CXP Analyis SW V2.2, 5 User Network, Automated
differential cell counter; Part Number 774178; Recall # Z-2031-2008;
q) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – SW Kit, CXP Analyis SW V2.2, 10 User Network, Automated
differential cell counter; Part Number 774179; Recall # Z-2032-2008;
r) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
and 2.2 – SW Kit, CXP Analyis SW V2.2, 15 User Network, Automated
differential cell counter; Part Number 774180; Recall # Z-2033-2008

REASON
Incorrect Display: In certain modes, the protocol will not initially display the correct data in some plots. In addition, when running EWL files, any edited SampleID1 is not automatically updated in all tubes in the panel.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on May 3 2007.
Manufacturer: Applied Cytometry, Sheffield, United Kingdom. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
501 units

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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