—#72513

Product

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

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K030828
Affected lot / code info: Part Numbers 626553, Version 2.2

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Globally to the United States and Canada.

Timeline

Recall initiated: 2007-08-01
Posted by FDA: 2009-01-07
Terminated: 2009-01-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72513. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.