Recall Z-1372-05 ยท JQP Calculator/Data Processing Module, For Clinical Use
Beckman Coulter Inc
DL 2000 Data Manager
| Date | Aug 16, 2005 (initiated Jun 20, 2005) |
| Status | Terminated |
| Reason | Version v6.4.109f, any result designated as 'calculated chemistry' at DL2000 may upload to the LIS with an incorrect or blank sample ID. |
| Root cause | Other |
| Action | Recall letters were sent during the week of June 20, 2005. It explains the problem and indicates that an enclosed software correction must be installed to correct the problem. |
| Quantity | 287 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.