Binding Site Recalls VaccZyme Human Anti-Haemophilus Influenza Type B Assay Kits
The Binding Site Group is recalling 462 VaccZyme assay kits due to performance deterioration that may cause falsely elevated antibody results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves inaccurate diagnostic results (falsely elevated antibody levels) rather than direct physical injury or a high-risk pathogen, fitting the criteria for moderate severity involving potential misdiagnosis or incorrect clinical assessment.
Plain-English summary
The Binding Site Group, Ltd. is recalling 462 units of the VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit (Product Code: MK016). The affected lots are 413170 and 435314, with UDI 05051700006767. These kits are used for in vitro diagnostic purposes to measure specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide in human serum.
The recall was initiated because a deterioration of performance was identified in the kits, specifically findings of a positive bias with kit controls. This issue may affect patient sample results, potentially leading to falsely elevated results that incorrectly indicate a protective level of anti-Hib antibody. This could impact the assessment of immunodeficiency.
The affected products were distributed worldwide, including nationwide in the United States in the states of Massachusetts, California, Missouri, North Carolina, Minnesota, Virginia, Washington, and Illinois, as well as in Canada. Users of these kits should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- 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…
- Manufacturer
- The Binding Site Group, Ltd.
- Affected units
- 462
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 05051700006767. Lot numbers 413170 and 435314.
Distribution
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