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Recall Observatory FDA recall evidence

Device product

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

Z-1454-2025

February 20, 2025

Class II

Product summary

Firm
Microbiologics Inc
Event
Event 96381
Status
Ongoing
Classification
Class II
Quantity
28 units
Official record key
device-enforcement:Z-1454-2025

Official wording

Reason: The RSV target may give a late Ct value and could potentially not pass QC.

Code information: UDI-DI: 10845357042184; Lot Number: HE0044-131

Distribution pattern: Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The RSV target may give a late Ct value and could potentially not pass QC.