NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
Check against the official notice below — it lists the full affected range.
NeuMoDx Molecular Inc. is recalling NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 due to reduced analytical sensitivity for samples in the 1x - 3x LOD (limit of detection) range for Flu A, RSV, and SARS-CoV-2 targets. This sensitivity issue may result in false negative test results, potentially allowing disease transmission to continue and delaying appropriate medical treatment for affected individuals.
The recalled test strips were distributed domestically to Florida, New York, Maryland, Pennsylvania, Virginia, Michigan, Tennessee, and New Mexico, as well as internationally to multiple countries including Austria, Australia, Belgium, Switzerland, Germany, Finland, France, the United Kingdom, Greece, Hong Kong, Indonesia, Italy, Lithuania, the Netherlands, Saudi Arabia, Sweden, and Slovenia. A total of 459 kits were distributed in the United States and 1,626 kits internationally. The affected cartridge lot numbers range from 111915 to 117508. The source does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 459 kits US; 1626 kits OUS Lot/code info: UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.