NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
- Company
- Neumodx Molecular Inc
- Recall Initiated
- May 13, 2022
- Recall Number
- Z-1251-2022
- Quantity
- 459 kits US; 1626 kits OUS
- Firm Location
- Ann Arbor, MI
Reason for Recall
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.
Distribution
Domestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution to AT, AU, BE, CH, DE, FI, FR, GB, GR, HK, ID, IT, LT, NL, SA, SE, and SI.
Lot / Code Info
UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508
Root Cause
Process control
Action Taken
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.