Recall Z-0267-05 ยท JQP Calculator/Data Processing Module, For Clinical Use
Beckman Coulter Inc
DL2000 Data Manager Software, Version 6.4.108
| Date | Nov 30, 2004 (initiated Nov 5, 2004) |
| Status | Terminated |
| Reason | Possibility of reporting an incorrect result occurs due to a software anomally. |
| Root cause | Other |
| Action | Letters were sent to sites on November 5, 2004 to confirm previous telephone conversations with the consignees. |
| Quantity | 3 |
| Distribution | Product was under evaluation at three sites in FL, IL, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.