VaccZyme Human Anti-Haemophilus influenza type b Enzyme… recallZ-1469-2020 · The Binding Site Group, Ltd. · initiated Aug 12, 2018

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from The Binding Site Group, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

On XXX, an Urgent Field Safety Notice was sent via email to customers. Customers are instructed to discontinue using this product immediately; dispose of any remaining product at your facility following local regulations; discuss this information with your medical director so that the potential impact of the issue is considered on a local level; and to return the completed and signed E-Back form TSWS18 to [email protected] or to your local firm representative within one week of receiving this notification. Customers are also requested to include a witness signature for the kit disposal as this is required on the E-Back form. Customers with additional questions were encouraged to email [email protected].

Recall details

Recall number: Z-1469-2020
Status: Terminated
Initiated by the company: Aug 12, 2018
Recalling firm: The Binding Site Group, Ltd.
Quantity: 462 kits
Product code: GRP
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.

Product description

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.

Code information (models, lots, serial numbers)

UDI: 05051700006767. Lot numbers 413170 and 435314.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

VaccZyme™ Human Anti-Haemophilus Influenzae type b Enzyme Immunoassay Kit MK016
The Binding Site Group Limited · Antisera, All Types, H. Influenza
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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