Recall Z-1440-05 ยท JQP Calculator/Data Processing Module, For Clinical Use
Beckman Coulter Inc
Aqueduct Hematology Workflow Manager, software
| Date | Aug 10, 2005 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 36 |
| Distribution | AK, AZ, CA, DE, FL, IN, KS, MA, MI, MN, MO, NC, NY, OH, PA, TX, VA, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.