Recall Z-1251-2022 ยท QLT Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
NeuMoDx Molecular Inc
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
| Date | May 13, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 459 kits US; 1626 kits OUS |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.