Recall Z-1149-04 ยท CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
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)
| Date | Jul 23, 2004 (initiated Jan 28, 2004) |
| Status | Terminated |
| Reason | Inconsistent and incomplete results for IgG. |
| Root cause | Other |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.