NeuMoDx Molecular Inc recalls NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 a…

Recall date

January 21, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0738-2022

FDA classification

Class II

Brand / firm

NeuMoDx Molecular Inc

Sold / distributed

US Nationwide distribution in the states of FL, MD, MI, NY.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.