NeuMoDx recalls test strips with lot 116305 S/L-02 (sublot 02) due to increased risk of SARS-CoV-2 false positives. Affected products may show incorrect positive results for COVID-19.
A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.
NeuMoDx is recalling test strips that could give false positive results for SARS-CoV-2. This means you might think you have COVID-19 when you don't, leading to unnecessary worry and actions.
The test strips have a risk of contamination that can cause false positive results for SARS-CoV-2. This means the test might show a positive result for COVID-19 when the person does not actually have the virus.
People who purchased the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strips with lot number 116305 S/L-02 (sublot 02) are affected. Those using the test strips for home COVID-19 screening are most at risk of false positives.
Check the lot number on the box: 116305 S/L-02 (sublot 02). The product is labeled with the reference number 300900 and distributed in boxes of 6 test strips.
Look for lot number 116305 S/L-02 (sublot 02) on the box or pouch.
No, the recall does not require stopping use. The risk is false positives, not a safety hazard.
Check the lot number on the box: 116305 S/L-02 (sublot 02). The product is labeled with reference number 300900 and comes in boxes of 6.
The recall does not specify a remedy, so you can continue using them but be aware of potential false positives.
We’ve drafted a message you can send NeuMoDx to request your refund or repair — edit it as you like.
Subject: Recall Z-0738-2022 — NeuMoDx NeuMoDx Hello, I own a NeuMoDx that is covered by recall Z-0738-2022 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.
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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.
