medical Class II Updated 2022-06-15

NeuMoDx Molecular Inc recalls NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No.

Recalled Product

NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900

Hazard / Issue

There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.

Issued by

FDA

Affected States: FL, NY, MD, PA, VA, MI, TN, NM, DE, ID
Lot/Code Info: UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508
View official government recall

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