Beckman Coulter Inc Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1, Automated differential cell counter, Part Number: 626554, Beckman Coulter, Fullerton, CA 92834 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data.

Recommended Action

Per FDA guidance

Consignees were notified by an Urgent Product Corrective Action letter sent on 6/29/07. The letter provided details on the data error and instruction on how to avoid the error. Users were asked to retain notification as part of the Quality Systems documentation and return a response form acknowledging receipt. For additional information, contact 1-800-526-7694.