Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is used for the q

FDA device recall Z-0129-2009 · posted 2009-01-13 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc

Reason for recall

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

GKZ

Quantity affected

594 Worldwide: 518 in the United States and 76 in Canada

Distribution

Globally - United States and Canada

Date initiated

2007-10-11

Date posted

2009-01-13

Date terminated

2009-01-13

Location

Brea, CA

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