NeuMoDx Molecular Inc NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 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, Model No. 300900
Brand
NeuMoDx Molecular Inc
Lot Codes / Batch Numbers
UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508
Products Sold
UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508
NeuMoDx Molecular Inc is recalling NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On May 13, 2022, the firm distributed Urgent Medical Device Correction letters to impacted customers. The letter informed customers of the reduced analytical sensitivity for Flu A, SARS-CoV-2, and RSV. The firm also specified that only the RSV target showed a similar reduction in clinical sensitivity; Influenza A and SARS-CoV-2 did not show a reduction in clinical sensitivity. Influenza B is not affected by this issue. The letter reminded users that negative results do not preclude infection with Influenza virus, RSV, and/or SARS-CoV-2, and the device should not be used as the sole basis for patient management and treatment decisions. Customers should share the notice with all affected users. If you have any questions regarding this recall, 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 noticeDistribution
As reported by FDA
DE, FL, ID, MD, MI, NM, NY, PA, TN, VA
Page updated: Jan 10, 2026