# FDA recall Z-1469-2020

> **The Binding Site Group, Ltd.** · Class II · device recall initiated 2018-08-12.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1469-2020
- **Recalling firm:** The Binding Site Group, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-12
- **Report date:** 2020-03-18
- **Termination date:** 2022-01-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Birmingham, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1469-2020

## Citation

> AI Analytics. FDA recall Z-1469-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1469-2020. Source: US FDA. Licensed CC0.

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