medical Class II Updated 2025-03-26

Microbiologics Inc recalls Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Wh

Recalled Product

Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N


Hazard / Issue

The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 10845357043563; Lot Number: HE0065-29
View official government recall

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