FDA-Device2022-03-16Class II
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.
NeuMoDx Molecular Inc
Hazard
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.
Sold states
US Nationwide distribution in the states of FL, MD, MI, NY.
Affected count
102 boxes
Manufactured in
1250 Eisenhower Pl, N/A, Ann Arbor, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0738-2022Don't want to check this manually?
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