FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. Part Numbers: 446360 (250 test kit) 446260 (50 test kit) 444970 (10 test kit)
- Recall number
- Z-1149-04
- Recalling firm
- Beckman Coulter Inc
- Product
- IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. Part Numbers: 446360 (250 test kit) 446260 (50 test kit) 444970 (10 test kit)
- Status
- Terminated
- Initiated
- 2004-01-28
- Posted
- 2004-07-23
- Terminated
- 2004-08-30
- Reason
- Inconsistent and incomplete results for IgG.
- Root cause
- Other
- Action
- not on file
- Quantity
- not on file
- Distribution
- not on file
- Lot, serial or model codes
- M308363 (250 test) M309039 (50 test) 10 test-- M307327, m307329, M307333, M310301, M310302, M310303, M310304, M310305, M305176.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CFF
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- 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