Recall Z-1469-2020 ยท GRP Antisera, All Types, H. Influenza
The Binding Site Group, Ltd.
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 duplica
| Date | Aug 12, 2018 |
| Status | Terminated |
| Reason | 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. |
| 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 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.