NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip recall
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
Why was NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip recalled?
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.
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?
UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508
- Product
- NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
- Recalling firm
- NeuMoDx Molecular Inc
- Quantity
- 459 kits US; 1626 kits OUS
- Distribution
- Domestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution to AT, AU, BE, CH, DE, FI, FR, GB, GR, HK, ID, IT, LT, NL, SA, SE, and SI.
- Recall date
- June 15, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)