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Terminated

Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1

FDA Recall Z-0197-2007 · Posted 2006-11-21

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2006-07-26
Date Terminated2012-02-29
Product Quantity416 (US) + 60 (Canada)

Reason for Recall

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.

Firm Action

Customer letter -- A Product Corrective Action (PCA) letter was sent the week of July 24, 2006 to all accounts that have FC500 with CXP Software 2.0 and 2.1 to inform them that a potential sample misidentification may occur when running a Work list with missing tube Location(s) in Automatic MCL mode. The letter outlines actions to be taken to avoid mis-identification of patient results.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030828TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)Beckman Coulter, Inc. · 2003-05-21

Official Source

View FDA Recall →

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

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