Z-1740-2022 Class III Terminated
FDA device recall Z-1740-2022 was initiated by Microbiologics Inc on July 27, 2022 and is designated Class III. Reason for recall: Product not registered for use in the UK The recall status is terminated (terminated August 2, 2024). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- September 21, 2022
- Initiation Date
- July 27, 2022
- Termination Date
- August 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
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
Reason for Recall
Product not registered for use in the UK
Distribution Pattern
International distribution to the country of United Kingdom.
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.