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Terminated

Cytomics FC500 with CXP Software

FDA Recall Z-0380-06 · Posted 2006-01-11

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJJF
Date Initiated2005-11-23
Date Terminated2012-01-26
Product Quantity179

Reason for Recall

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

Firm Action

A Product Corrective Action letter will be mailed the week of Nov 28, 2005 to all FC500 wi CXP Software customers. Each user will be contacted initially and then once more (if needed) in order to determine the rate of response from the Response form provided.

Root Cause

Software change control

Distribution Pattern

Nationwide and Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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