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.
This recall has been terminated (originally issued August 12, 2018).
- Company
- The Binding Site Group, Ltd.
- Recall Initiated
- August 12, 2018
- Terminated
- January 20, 2022
- Recall Number
- Z-1469-2020
- Quantity
- 462 kits
- Firm Location
- Birmingham United Kingdom
- Official Source
- View on FDA website ↗
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
Worldwide distribution - US Nationwide distribution in the states of M.A., C.A., MO., NC, MN, VA, WA, and IL and country of Canada.
Lot / Code Info
UDI: 05051700006767. Lot numbers 413170 and 435314.
Root 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.