Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus — Class II medical device recall Z-1371-2025
Ongoing recall by Microbiologics Inc, reported 2025-03-26, distributed nationwide. The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
| Recall number | Z-1371-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2025-02-20 |
| Classified | 2025-03-14 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Quantity | 6 units |
| UPC / GTIN / UDI-DI | 10845357043563 |
| Lot numbers | HE0065-29 |
| Model numbers | HE0065N |
Product
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Reason for recall
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
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-1371-2025. 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.