FDA Device recall Z-1371-2025
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog…
- FDA Device
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog… by Microbiologics, citing the A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1371-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-20 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Microbiologics |
| Distribution | US |
Product
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Reason
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Identifiers
| code_info | UDI-DI: 10845357043563; Lot Number: HE0065-29 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1371-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.