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 hum
Check against the official notice below — it lists the full affected range.
The Binding Site Group, Ltd. has recalled VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kits (Product Code: MK016) due to deterioration of performance identified in the kits. The kits showed a positive bias in controls, which means patient sample results may be falsely elevated, incorrectly indicating that a person has protective levels of anti-Hib antibody when assessing for immunodeficiency. A total of 462 kits were affected, with lot numbers 413170 and 435314.
The recalled kits were distributed worldwide and in the United States in Massachusetts, California, Missouri, North Carolina, Minnesota, Virginia, Washington, and Illinois, as well as Canada. The recall record does not specify what remedy affected consumers should pursue.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 462 kits Lot/code info: UDI: 05051700006767. Lot numbers 413170 and 435314.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.