—#49407

Product

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

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
Affected lot / code info: System with MXP Software Version 2.0 & 2.1

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2006-10-17
Posted by FDA: 2006-12-27
Terminated: 2012-02-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49407. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.