Recall Z-1469-2020
The Binding Site Group, Ltd. · initiated August 12, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: UDI: 05051700006767. Lot numbers 413170 and 435314.
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 taken
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.
Details
- Recall number
- Z-1469-2020
- Initiated
- August 12, 2018
- Terminated
- January 20, 2022
- Product code
- GRP – Antisera, All Types, H. Influenza
- 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.
- Recalling firm
- The Binding Site Group, Ltd., Birmingham