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U.S. Department of Health and Human Services

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Medical Device Notification: StemCXP Software, Version 1.0-Beckman Coulter, Inc

DATE NOTIFICATION INITIATED:

February 24, 2005

PRODUCT:

StemCXP Software Version 1.0 for Cytomics FC 500
Part Number - 628843

MANUFACTURER:

Beckman Coulter, Inc
Brea, CA

REASON:

Beckman Coulter issued an "Urgent: Product Corrective Action" Notification relating to two issues with stemCXP Software.

Issue #1: Under certain conditions a locked stemCXP protocol could present a situation where there would be an incorrect placement of regions. This could cause falsely increased CD34+ Absolute Count values.

Issue #2: When the 7HPCSA protocol is run, the Results Analysis box may be displayed on the screen and included in the printouts. If the protocol is run and then the regions are modified, the values in the Results Analysis box will not reflect the modified regions. Immediate user preventive actions were provided in the notification.

 

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