FDA Device recall Z-1740-2022
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N
- FDA Device
- Class III
- terminated
- Published 2022-09-21
On 2022-09-21 the FDA classified a Class III recall of Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N by Microbiologics, citing product not registered for use in the UK.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1740-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-07-27 |
| Published | 2022-09-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | n/a |
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
Reason
Product not registered for use in the UK
Identifiers
| code_info | a. UDI Number: 10845357043846, Lot Number: HE0071-01-1, Expiration Date: 12/31/2022. b. UDI Number: 10845357043945, Lot…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1740-2022%22
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