Product Recalls & Refunds Online / National

NeuMoDx Molecular Inc: NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Recall 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.. Recalled by NeuMoDx Molecular Inc. 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.. Classification (Class II — potential health risk). Affected lots/dates: UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508. Contact the manufacturer or the retailer where you purchased this device to arrange for

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer
Category Product Recalls & Refunds
Location National
Eligibility U.S. consumers who own or purchased the recalled medical device. Contact the manufacturer or the retailer/pharmacy where you purchased it to arrange for a free correction, repair, or replacement. Have the model number ready if possible.
Source Official Source ↗
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