Reported Mar 16, 2022 · Ongoing
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6…
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, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.
- Lot codes and dates
- Lot116305 S/L-02 (Sublot 02)
- UDI10814278020830
- Amount recalled
- 102 boxes
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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