VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay… — Class II medical device recall Z-1469-2020
Terminated recall by The Binding Site Group, Ltd., reported 2020-03-18, distributed nationwide. A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with findings of a
| Recall number | Z-1469-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Binding Site Group, Ltd., Birmingham, United Kingdom |
| Recall initiated | 2018-08-12 |
| Classified | 2020-03-11 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2022-01-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 462 kits |
| UPC / GTIN / UDI-DI | 05051700006767 |
| Lot numbers | 413170, 435314 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1469-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.