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.
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.
The kits may produce false positive results when testing for anti-Hib antibodies. This means they could incorrectly show that a patient has protective antibodies when they actually do not, potentially leading to misdiagnosis of immunodeficiency.
Healthcare providers using the VaccZyme kits for immunodeficiency testing are most at risk. The recall affects specific lot numbers of the kits used in medical labs.
Check for lot numbers 413170 or 435: The kits were sold with these specific lot numbers and product code MK016.
Look for lot numbers 413170 or 435314 on the kit packaging.
The kits may produce false positive results, which could incorrectly indicate protective antibody levels in immunodeficiency testing.
Check the lot number on the kit packaging. If it's 413170 or 435314, contact The Binding Site Group for instructions.
No, the recall is for potential false positive results in medical testing, not a physical hazard.
We’ve drafted a message you can send The Binding Site Group to request your refund or repair — edit it as you like.
Subject: Recall Z-1469-2020 — The Binding Site Group The Binding Site Group Hello, I own a The Binding Site Group that is covered by recall Z-1469-2020 from The Binding Site Group. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
