Z-1149-04

IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon...

Name: Z-1149-04 IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon...
Creator: Beckman Coulter Inc
Published: 2004-01-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-01-28 / Terminated

FDA source

Beckman Coulter Inc began a recall of IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. Part... on 2004-01-28. The reason FDA records is "Inconsistent and incomplete results for IgG". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1149-04
Status: Terminated
Initiated: 2004-01-28
Posted: 2004-07-23
Terminated: 2004-08-30
Recalling firm: Siemens Healthcare Diagnostics 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)
Product code: CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Reason for recall: Inconsistent and incomplete results for IgG.
FDA root cause: Other
Product codes and lots: M308363 (250 test) M309039 (50 test) 10 test-- M307327, m307329, M307333, M310301, M310302, M310303, M310304, M310305, M305176.

Product code CFF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)