Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For Recalled by The Binding Site Group, Ltd. Due to A deterioration of performance was identified with influenza...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact The Binding Site Group, Ltd. directly.
Affected Products
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.
Quantity: 462 kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About The Binding Site Group, Ltd.
The Binding Site Group, Ltd. has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report