The Binding Site Group recalls VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kits due to potential false positive results in immunodeficiency testing. Affected kits may show falsely elevated antibody levels.
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.
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Contact the company
📍Recalling firmThe Binding Site Group, Ltd.8 Calthorpe Road · Birmingham, United Kingdom
✎ GovInfoNow plain-language explainer
The Binding Site Group is recalling certain VaccZyme anti-Hib enzyme immunoassay kits because they can give false positive results, meaning they might incorrectly indicate a protective level of antibodies in immunodeficiency tests. This could lead to inaccurate health assessments. Read more at govinfonow.com/recall/70075-vacczyme-anti-hib-kit-recall-false-positive-results-risk.
“VaccZyme Anti-Hib Kit Recall: False Positive Results Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70075-vacczyme-anti-hib-kit-recall-false-positive-results-risk. Based on FDA recall #Z-1469-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1469-2020%22&limit=1).
The FDA announced on Aug. 12, 2018, that The Binding Site Group Ltd. voluntarily recalled VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kits due to performance deterioration causing falsely elevated results. The agency issued recall number Z-1469-2020 for the Class II device.
How to tell if you have it
Brand: The Binding Site Group
Product: VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use
Product Code: MK016
Lot numbers: 413170 and 435314
Quantity: 462 kits
The hazard
The recall addresses a positive bias with kit controls that may affect patient sample results by incorrectly indicating a protective level of anti-Hib antibody in the assessment of immunodeficiency. The FDA stated this deterioration of performance could lead to inaccurate diagnostic outcomes.
Context
GovInfoNow's records show The Binding Site Group, Ltd. has had 15 other recalls on record since Aug. 23, 2017. Other recent recalls of similar products include EXENT Analyser Software Version 1.0.20 (April 16, 2026), Freelite Human Lambda Free Kit (Oct. 15, 2021), and FREELITE Human Kappa Free Kit (May 20, 2021). Other recent recalls of similar products include Sperm Ab ELISA Test Kit (July 2, 2026), Hologic Aptima HPV Assay Kit (Feb. 18, 2026), and BioFire Joint Infection Panel (April 22, 2026).
How to tell if you have this one
Check for lot numbers 413170 or 435: The kits were sold with these specific lot numbers and product code MK016.
Brand
The Binding Site Group
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for lot numbers 413170 or 435314 on the kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of M.A., C.A., MO., NC, MN, VA, WA, and IL and country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, Minnesota, Missouri, North Carolina, Virginia, Washington.
Recall timeline
FDA terminated this recall 3.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1469-2020 (August 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1469-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.