NeuMoDx recalls Flu A-B/RSV/SARS-CoV-2 Vantage Test Strips (Model 300900) due to potential false negatives in certain samples, which could lead to undetected infections and delayed treatment.
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.
NeuMoDx is recalling Flu A-B/RSV/SARS-CoV-2 Vantage Test Strips (Model 300900) because they might give false negative results for some infections. This could mean people don't know they're infected and might spread illness or delay treatment.
The test strips might not detect infections in samples with low to moderate virus levels (1x - 3x LOD range). This could cause false negative results, meaning infected people might not know they're sick and could spread illness to others or delay treatment.
People who use these test strips for home testing of flu, RSV, or SARS-CoV-2 may be affected. Those with weaker immune systems or in high-risk groups could be at slightly higher risk due to potential false negatives.
Check for the model number 300900 on the test strip packaging. The product was sold with lot numbers 111915 to 117508.
Look for the model number 300900 on the test strip packaging to confirm if it's recalled.
The test strips may give false negative results for some infections, which could lead to undetected transmission and delayed treatment.
Check the model number on the packaging. If it's 300900 with lot numbers 111915-117508, you should stop using it and contact NeuMoDx for guidance.
No, the recall is for potential false negatives, not physical harm. The risk is related to undetected infections, not injury.
We’ve drafted a message you can send NeuMoDx to request your refund or repair — edit it as you like.
Subject: Recall Z-1251-2022 — NeuMoDx NeuMoDx Hello, I own a NeuMoDx that is covered by recall Z-1251-2022 from NeuMoDx. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
