Recall Z-1245-06 ยท LOQ Device, General Purpose, Hematology
Beckman Coulter Inc
Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834
| Date | Jul 18, 2006 (initiated Apr 17, 2006) |
| Status | Terminated |
| Reason | Beckman has confirmed that erroneous results could be reported when the workstation database crashes. |
| Root cause | Other |
| Action | A Product Corrective Action (PCA) letter was sent week of April 17, 2006 via US mail. The letter outlines action to be taken to avoid potential erroneous results. Firm targeting 75% effectivenss checks. |
| Quantity | 759 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032000 | COULTER LH 500 HEMATOLOGY ANALYZER Beckman Coulter, Inc., Aug 13, 2003 |