IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus I
FDA device recall Z-0994-05 · posted 2005-07-16 · Terminated
Recall details
- Recalling firm
- DPC Cirrus
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- There are 941 units in the United States and 3014 units in the international market.
- Distribution
- worldwide
- Date initiated
- 2005-04-22
- Date posted
- 2005-07-16
- Date terminated
- 2006-06-29
- Location
- Flanders, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER (K970227) | Dpc Cirrus | 1997-04-08 |