Medical Device Test Strip Recall: Potential False Negatives for Respiratory Pathogens
NeuMoDx Flu A-B/RSV/SARS-CoV-2 test strips may produce false negative results for low viral loads, delaying diagnosis and treatment. The recall affects 459 U.S. kits and 1,626 international kits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with analytical sensitivity deficiency that can produce false negative results, delaying diagnosis and risking disease transmission. While no illnesses have been reported, the potential for false negatives in diagnostic testing presents a significant risk of harm.
Plain-English summary
NeuMoDx Molecular Inc is recalling the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (Model No. 300900) due to reduced analytical sensitivity that could lead to false negative results.
The test strips may fail to detect Flu A, RSV, or SARS-CoV-2 when samples contain viral loads in the 1x to 3x LOD (Limit of Detection) range. False negative results could delay appropriate patient treatment and allow continued disease transmission.
The recall affects 459 kits distributed within the United States (Florida, New York, Maryland, Pennsylvania, Virginia, Michigan, Tennessee, and New Mexico) and 1,626 kits distributed internationally to Austria, Australia, Belgium, Switzerland, Germany, Finland, France, Great Britain, Greece, Hong Kong, Indonesia, Italy, Lithuania, Netherlands, Saudi Arabia, Sweden, and Slovenia. Affected cartridge lot numbers range from 111915 to 117508, identified by UDI-DI (GTIN): 10814278020830.
Healthcare providers and laboratories using these test strips should verify their lot numbers against the recall information. If using affected lots, retesting of negative results may be warranted, particularly in patients with clinical symptoms consistent with respiratory infection. Contact NeuMoDx Molecular Inc or the FDA for guidance on device replacement or return.
The recalled product
- Product
- NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
- Manufacturer
- NeuMoDx Molecular Inc
- Hazard
- false-negative
- missed-diagnosis
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508
Distribution
Distributed in 10 states:
- DE
- FL
- ID
- MD
- MI
- NM
- NY
- PA
- TN
- VA
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