Class II
Medical Device Recall: Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Microbiologics Inc · February 20, 2025
Reason for Recall
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Distribution
US Nationwide distribution in the states of TX. UK.
States Affected
NATIONWIDE
Quantity Affected
6 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1371-2025
Status: ongoing
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