29

Nov

2006

Beckman Coulter Inc.. Class II

0

Company: Beckman Coulter Inc
Date of Enforcement Report:11/29/2006
Class:ll

PRODUCT
Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1, Recall # Z-0197-2007

REASON
Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube through the remaining protocols and will generate results and printouts of these runs leading to a Mis-Identification condition.

CODE
Part Numbers: 722645 Software Kit; CXP version 2.1 New User; 723113 Software Kit;
CXP version 2.1 Upgrade; 629637 Software Kit;
CXP version 2.0 New User; 629636 Software Kit;
CXP version 2.0 Upgrade; 626553 TN;
FC500 WITH UPS; 6605627 TN;
5 CLR, FC500 (IOOV); 6605628 TN;
5 CLR, FC500 (120V); 6605629 TN;
5 CLR, FC500 (220V); 6605630 TN;5 CLR, FC500 (240V)

RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea,CA., by letters the week of July 24, 2006.
Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
476 units

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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