NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip recall: Contamination
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…
Why was NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830
- Product
- 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…
- Recalling firm
- NeuMoDx Molecular Inc
- Quantity
- 102 boxes
- Distribution
- US Nationwide distribution in the states of FL, MD, MI, NY.
- Recall date
- March 16, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)