Beckman Coulter Inc Aqueduct Hematology Workflow Manager, software Recall

Check Your Product

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

Reason for Recall

As stated by FDA

Potentail for misidentification of historical patient results within the Aqueduct Hematology Workflow Manager software. In instances where the workflow manager software receives the same patient identifier for more than one patient the Aqueduct Workflow Manager software merges all results into one Patient File. The may cause test results to be associated with the wrong patient.

Recommended Action

Per FDA guidance

A Product corrective action letter to be mailed the week of August 8, 2005, to all customers directing that each patient is identified with a truly unique patient identifier.

Distribution

As reported by FDA

AK, AZ, CA, DE, FL, IN, KS, MA, MI, MN, MO, NY, NC, OH, PA, TX, VA, WA