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.
- Company
- Neumodx Molecular Inc
- Recall Initiated
- January 21, 2022
- Recall Number
- Z-0738-2022
- Quantity
- 102 boxes
- Firm Location
- Ann Arbor, MI
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
US Nationwide distribution in the states of FL, MD, MI, NY.
Lot / Code Info
Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830
Root Cause
Under Investigation by firm
Action Taken
Customers were contacted by phone 21 Jan 2022 and sent a follow up email with instructions to stop using Lot 116305 S/L02, discard remaining inventory, and review all SARS-CoV-2 positive results previously obtained using the affected product lot to exclude erroneous diagnosis and treatment. Customers are to forward this information to all individuals and departments within their organization using the affected product. If you have any questions regarding this notice, please contact QIAGEN Technical Services at 1-800-362-7737 or techservice-na@qiagen.com.