Microbiologics Inc is recalling 6 units of the Helix Elite Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet). This multi-analyte, unassayed quality control material (Catalog Number HE0065N) is used in laboratory testing to ensure sample adequacy. The recall was initiated because the A549 human cell target may give a late Cycle threshold (Ct) value, which can affect the accuracy of testing controls.
A late Ct value in the human cell target could lead to inaccurate sample adequacy assessments in diagnostic tests, potentially causing unreliable results. No incidents or injuries have been reported to date.
Recall #: Z-1371-2025; Quantity: 6 units
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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