FDA Medical Device Recalls (openFDA)
DPC Cirrus: Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.
- Recall number
- Z-0263-05
- Recalling firm
- DPC Cirrus
- Product
- Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.
- Status
- Terminated
- Initiated
- 2004-10-29
- Posted
- 2004-11-30
- Terminated
- 2005-01-18
- Reason
- Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'.
- Root cause
- Other
- Action
- The firm faxed the technical bulletin notification to each domestic customer on 10/22/2004. International customers were e-mailed and faxed on the same day.
- Quantity
- 17 UNITS
- Distribution
- The firm distributed the IMMULITE 2500 nationwide and internationally. The international customers are located in Portugal, Turkey, Australia, Switzerland, Czech Rep.,Germany, Spain, France, Netherlands, Sweden, Denmark, United Kingdom, and Italy.
- Lot, serial or model codes
- Serial Number: B0071; B0095; B0055; B0060; B0124; B0131; B0097; B0106; B0064; B0087; B0073; B0113; B0121; B0135; B0122; B0123; B0102.
- 510(k) numbers
- ["K033234"]
- PMA numbers
- not on file
- Product code
- DHA
- 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