Beckman Coulter Inc CXP software for Cytomics FC500 Cytometer Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CXP software for Cytomics FC500 Cytometer
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Versions 1.0, 1.1, and 2.0
Products Sold
Versions 1.0, 1.1, and 2.0
Beckman Coulter Inc is recalling CXP software for Cytomics FC500 Cytometer due to Incorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect.
Recommended Action
Per FDA guidance
The Product Corrective Action Customer Letter which includes Modified Operating Instructions was sent to US and Canadian customers the week of November 8, 2004 via US Mail.
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