FDA Medical Device Recalls (openFDA)
DPC Cirrus: IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836
- Recall number
- Z-0994-05
- Recalling firm
- DPC Cirrus
- Product
- IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836
- Status
- Terminated
- Initiated
- 2005-04-22
- Posted
- 2005-07-16
- Terminated
- 2006-06-29
- 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
- Lot, serial or model codes
- All analyzers; all serial numbers.
- 510(k) numbers
- ["K970227"]
- 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