Device 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 pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.
Z-0738-2022
Product summary
- Event
- Event 89675
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 102 boxes
- Official record key
device-enforcement:Z-0738-2022
Official wording
Reason: 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.
Code information: Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830
Distribution pattern: US Nationwide distribution in the states of FL, MD, MI, NY.
Derived failure modes
-
Unknown
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.