Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1454-2025 — Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N

U.S. FDA — Device Enforcement · United States · 2025-02-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1454-2025
Date of alert
2025-02-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Microbiologics Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10845357042184
Reported risk: The RSV target may give a late Ct value and could potentially not pass QC.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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