Z-0738-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 16, 2022
- Initiation Date
- January 21, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102 boxes
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of FL, MD, MI, NY.
Code Information
Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830