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Terminated

Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2

FDA Recall Z-0455-2009 · Posted 2009-01-07

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2007-08-01
Date Terminated2009-01-13
Product Quantity565

Reason for Recall

Software error: The recall was initiated after Beckman Coulter identified that the CXP User documentation does not adequately characterize the use of the Live Gate feature. The primary use of a Live Gate is for the international removal of unwanted events, such as debris. The data outside of the Live Gate will not be stored to the final listmode file, this reducing the data set size. The softwa

Firm Action

The customer notifications were initiated by Beckman Coulter on July 23, 2007 when a Product Corrective Action (PCA) was mailed via US Postal Service to all affected customers. The PCA informed the customers that the user documentation does not adequately characterize the use of the Live Gate feature. The letter provides the customer with explanation of Live Gate and actions to be taken. For further information, please contact Beckman Coulter, Inc. by telephone at 714-993-5321.

Root Cause

Software design

Distribution Pattern

Globally to the United States 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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