Recall Z-0994-05 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
DPC Cirrus
IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836
| Date | Jul 16, 2005 (initiated Apr 22, 2005) |
| Status | Terminated |
| Reason | The Transport Chain is used to move a Reaction Tube within the Immulite 2000. It goes on to state the error condition that occurs due to a false trip of the home sensor. |
| Root cause | Other |
| Action | The firm became aware of the problem on 4/19 and conducted tests on 4/22/05. A service alert for field service engineers and Immulite 2000 distributors was prepared on 4/22/05. |
| Quantity | There are 941 units in the United States and 3014 units in the international market. |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970227 | IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER Dpc Cirrus, Apr 8, 1997 |