Class 2 Device Recall VaccZyme Human AntiHaemophilus

• Date Initiated by Firm: August 12, 2018
• Create Date: March 11, 2020
• Recall Status: Terminated on January 20, 2022
• Recall Number: Z-1469-2020
• Recall Event ID: 84899
• Product Classification: Antisera, all types, h. Influenza - Product Code GRP
• 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.
• Code Information: UDI: 05051700006767. Lot numbers 413170 and 435314.
• FEI Number: 3002808340
• Recalling Firm/ Manufacturer: The Binding Site Group, Ltd.; 8 Calthorpe Road; Birmingham United Kingdom
• Manufacturer 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 Determined 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 Technical.Support@bindingsite.com 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 Technical.support@bindingsite.com.
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.