Device product
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
Z-1740-2022
Product summary
- Event
- Event 90761
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2
- Official record key
device-enforcement:Z-1740-2022
Official wording
Reason: Product not registered for use in the UK
Code information: a. UDI Number: 10845357043846, Lot Number: HE0071-01-1, Expiration Date: 12/31/2022. b. UDI Number: 10845357043945, Lot Number: HE0073-02-2, Expiration Date: 02/28/2023.
Distribution pattern: International distribution to the country of United Kingdom.
Derived failure modes
-
Unknown
Product not registered for use in the UK