Helix Elite Inactivated Standard — Class III medical device recall Z-1740-2022
Terminated recall by Microbiologics Inc, reported 2022-09-21. Product not registered for use in the UK
| Recall number | Z-1740-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2022-07-27 |
| Classified | 2022-09-16 |
| Reported by FDA | 2022-09-21 |
| Terminated | 2024-08-02 |
| Countries outside the US | GB |
| Quantity | 2 |
| UPC / GTIN / UDI-DI | 10845357043846, 10845357043945 |
| Lot numbers | HE0071-01-1, HE0073-02-2 |
| Model numbers | HE0071N, HE0073N |
| Expiration dates | 2022-12-31, 2023-02-28 |
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 for recall
Product not registered for use in the UK
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1740-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.