Recall Z-0904-04 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc
UniCel Dxl 800 Access Immunoassay System, P/N 973100.
| Date | Jul 20, 2004 (initiated Mar 29, 2004) |
| Status | Terminated |
| Reason | Software coding error may cause a fatal error message. |
| Root cause | Other |
| Action | Each user will be contacted initially and then once more to ensure that the users have recieved the recall letter and have installed the new software included with the letter. Recall letters were sent March 29, 2003. |
| Quantity | 73 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023764 | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 Beckman Coulter, Inc., Jan 28, 2003 |