FDA Device recall Z-0738-2022
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947)
- FDA Device
- Class II
- ongoing
- Published 2022-03-16
On 2022-03-16 the FDA classified a Class II recall of NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947) by Neumodx Molecular, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0738-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-21 |
| Published | 2022-03-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Neumodx Molecular |
| Distribution | US |
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.
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.
Identifiers
| code_info | Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0738-2022%22
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