VaccZyme Human Anti-Haemophilus influenza type b Enzyme recall
VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay…
Why was VaccZyme Human Anti-Haemophilus influenza type b Enzyme 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 05051700006767. Lot numbers 413170 and 435314.
- Product
- VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay…
- Recalling firm
- The Binding Site Group, Ltd.
- Quantity
- 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.
- Recall date
- March 18, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)