Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.
FDA device recall Z-1138-03 · posted 2003-08-20 · Terminated
Recall details
- Recalling firm
- DPC Cirrus
- Reason for recall
- Version 2.6 software was released however it will not properly handle adjustment slopes.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 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.
- Date initiated
- 2003-06-13
- Date posted
- 2003-08-20
- Date terminated
- 2004-11-01
- Location
- Flanders, NJ
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