medical Class II Updated 2022-03-16

NeuMoDx Molecular Inc recalls NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300

Recalled Product

NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.


Hazard / Issue

A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830
View official government recall

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