The Binding Site Group, Ltd. recalls VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immu
Recalled Product
VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide, present in human serum. Sufficient materials are supplied to allow a maximum of 41 samples to be tested in duplicate, with a calibration curve and two controls.
Hazard / Issue
A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with findings of a positive bias with kit controls. Patient sample results may be affected with falsely elevated results incorrectly indicating a protective level of anti-Hib antibody in the assessment of immunodeficiency.
Issued by
FDA
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