Reported Jun 15, 2022 · Ongoing
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
NeuMoDx Molecular Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NeuMoDx Molecular Inc · 1250 Eisenhower Pl · Ann Arbor, MI · 48108-3281
Is this the product you have?
- NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
- Lot codes and dates
- UDI-DI (GTIN)10814278020830 Cartridge lot numbers 111915 - 117508
- Amount recalled
- 459 kits US; 1626 kits OUS
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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