—#70964

Product

Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is used for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.

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

Why it was recalled

Software error: This field action was initiated after Beckman Coulter determined that the CXP software does not refresh the dataset automatically under certain circumstances. The User documentation does not clearly state that the user should refresh the dataset after changes are made.

Root cause (FDA determination)

Software design

Action the firm took

Software error: A Product corrective Action (PCA) letter was mailed via US Postal Service on October 17, 2007 to all Cytomics FC 500 Flow Cytometry System with CXP Software accounts. This letter was entitled "URGENT: PRODUCT CORRECTIVE ACTION." Customers were informed that the user documentation does not clearly state that the user should refresh the dataset after changes are made. The letters provide the customers with an explanation and action to be taken whenever a protocol containing data is modified by making changes to cytosettings, regions or gates. Customer were instructed to review all data plots and results before reporting results out. any uncharacteristic patterns in the data or unexpected results must be verified by running Quality Control and if necessary, preparing new samples. In addition, customer were instructed to please share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Also they were asked to complete and return the an attached Customer Response Form within ten days. Customers with questions or concerns regarding the notification, could call Beckman Coulter Customer Service at 1-800-526-7694 in the United States or Canada. Outside the US and Canada, they were to contact their local Beckman Coulter Representative.

Recalling firm

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

Distribution

Distribution pattern: Globally - United States and Canada

Timeline

Recall initiated: 2007-10-11
Posted by FDA: 2009-01-13
Terminated: 2009-01-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70964. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.