FDA Device recall Z-1454-2025
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control mater…
- FDA Device
- Class II
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class II recall of Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control mater… by Microbiologics, citing the RSV target may give a late Ct value and could potentially not pass QC.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1454-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-20 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Microbiologics |
| Distribution | US |
Product
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
Reason
The RSV target may give a late Ct value and could potentially not pass QC.
Identifiers
| code_info | UDI-DI: 10845357042184; Lot Number: HE0044-131 |
|---|
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-1454-2025%22
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