Z-1469-2020Class II

VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use

Name: Z-1469-2020 VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use
Creator: The Binding Site Group, Ltd.
Published: 2018-08-12
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2018-08-12 / Terminated

FDA source

The Binding Site Group, Ltd. began a recall of VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is... on 2018-08-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1469-2020
Classification: Class II
Status: Terminated
Initiated: 2018-08-12
Posted: 2020-03-11
Terminated: 2022-01-20
Recalling firm: The Binding Site Group Ltd.
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.
Product code: GRP Antisera, All Types, H. Influenza
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.
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 462 kits
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 codes and lots: UDI: 05051700006767. Lot numbers 413170 and 435314.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1469-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1469-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-11

Product code GRP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)