FDA Medical Device Recalls (openFDA)
DPC Cirrus: Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.
- Recall number
- Z-1138-03
- Recalling firm
- DPC Cirrus
- Product
- Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.
- Status
- Terminated
- Initiated
- 2003-06-13
- Posted
- 2003-08-20
- Terminated
- 2004-11-01
- 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.
- Lot, serial or model codes
- All units.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1000122204
- Firm city
- Flanders
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28