NeuMoDx Molecular Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
NeuMoDx Molecular Inc
Lot Codes / Batch Numbers
Lot: 116305 S/L-02 (Sublot 02), UDI: 10814278020830
Products Sold
Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830
NeuMoDx Molecular Inc is recalling NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distrib due to 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 r. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Customers were contacted by phone 21 Jan 2022 and sent a follow up email with instructions to stop using Lot 116305 S/L02, discard remaining inventory, and review all SARS-CoV-2 positive results previously obtained using the affected product lot to exclude erroneous diagnosis and treatment. Customers are to forward this information to all individuals and departments within their organization using the affected product. If you have any questions regarding this notice, please contact QIAGEN Technical Services at 1-800-362-7737 or techservice-na@qiagen.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026