NeuMoDx Molecular Inc Recall 89675
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.
NeuMoDx Molecular Inc Recall 89675 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0738-2022 |
| Event ID | 89675 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of FL, MD, MI, NY. |
| Quantity | 102 boxes |
| Recall 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. |
| Device Classification | 20220316 |
| Device Code Info | Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830 |
| Center Classification Date | 20220308 |
| Recall Initiation Date | 20220121 |
| Recalling Firm | NeuMoDx Molecular Inc |
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