FC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware

FDA device recall Z-0317-2007 · posted 2006-12-27 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc

Reason for recall

The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. Issue limited only to protocols utilizing the Ratio parameter such as LeukoSure and DNA Cell Cycle.

Action taken

A Product Corrective Action (PCA) letter was mailed on Oct 17, 2006 to FC500 MPL and MXP software accounts. They are informed that if the operator opens the Parameter Selection Dialogue box after parameters have been selected for the RATIO Parameter, the selected parameters could revert back to the default choices. If these same parameters were used in the creation of the RATIO Parameter in any other saved protocol, the protocols will also be changed once they are opened after the error occurs. An immediate user preventive action to remedy this issue each time acquisition of samples that require a protocol utilizing the ratio parameter is desired is given within the letter. Consignees are asked to complete and return the enclosed Response Form within 10 days.

Root cause

Other

Status

Terminated

Product code

GKZ

Quantity affected

37 units in the US; 4 units in Canada

Distribution

Nationwide and Canada

Date initiated

2006-10-17

Date posted

2006-12-27

Date terminated

2012-02-29

Location

Brea, CA