Recall Z-0987-04 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
Coulter AcT 5diff Autoloader (AL) Hematology Analyzer
| Date | Jul 20, 2004 (initiated Apr 20, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 70 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030291 | COULTER ACT 5DIFF AUTOLOADER (AL) Beckman Coulter, Inc., Apr 17, 2003 |