FDA Device recall Z-1251-2022
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
- FDA Device
- Class II
- ongoing
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 by Neumodx Molecular, citing there is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allow….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1251-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-13 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Neumodx Molecular |
| Distribution | DE, FL, ID, MD, MI, NM, NY, PA, TN, VA |
Product
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
Reason
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.
Identifiers
| code_info | UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508 |
|---|
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-1251-2022%22
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