Recall Z-1138-03 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
DPC Cirrus
Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.
| Date | Aug 20, 2003 (initiated Jun 13, 2003) |
| Status | Terminated |
| Reason | Version 2.6 software was released however it will not properly handle adjustment slopes. |
| Root cause | Other |
| Action | Recall Technical Bulletins were sent out on 6/13/2003 to all Immulite 2000 users instructing them to not install the provided version 2.6 software. |
| Quantity | 434 upgrades |
| Distribution | Software was distributed to Immulite 2000 users throughout the nation. These units are found in hospitals and clinics. Software was also distributed to the firm''s service representatives. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.