—#32880

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)

FDA product code: CFF — Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Device class: Class 2
Medical specialty: Immunology
Affected lot / code info: M308363 (250 test) M309039 (50 test) 10 test-- M307327, m307329, M307333, M310301, M310302, M310303, M310304, M310305, M305176.

Why it was recalled

Inconsistent and incomplete results for IgG.

Root cause (FDA determination)

Other

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Timeline

Recall initiated: 2004-01-28
Posted by FDA: 2004-07-23
Terminated: 2004-08-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #32880. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.