Beckman Coulter Inc Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Versions 1.1 and 2.0
Products Sold
Versions 1.1 and 2.0
Beckman Coulter Inc is recalling Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0 due to Software anomally. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software anomally. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results.
Recommended Action
Per FDA guidance
Letters issued to users on July 13, 2005 which also included modified operating instructions, and response cards.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026