Z-1469-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 18, 2020
- Initiation Date
- August 12, 2018
- Termination Date
- January 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 462 kits
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.
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 Pattern
Worldwide distribution - US Nationwide distribution in the states of M.A., C.A., MO., NC, MN, VA, WA, and IL and country of Canada.
Code Information
UDI: 05051700006767. Lot numbers 413170 and 435314.