Beckman Coulter Inc Coulter AcT 5diff Autoloader (AL) Hematology Analyzer Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Coulter AcT 5diff Autoloader (AL) Hematology Analyzer
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
All software versions (1.00 & 1.20)
Products Sold
All software versions (1.00 & 1.20)
Beckman Coulter Inc is recalling Coulter AcT 5diff Autoloader (AL) Hematology Analyzer due to Software anomaly causes sample results to be not credible, reported as '0' or left blank. The next sample will also be incorrectly reported for the sa. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software anomaly causes sample results to be not credible, reported as '0' or left blank. The next sample will also be incorrectly reported for the same parameter.
Recommended Action
Per FDA guidance
Firm sent recall letter on or about April 20, 2004 informing users of the issue. Firm will implement a software solution in the near future.
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