FDA Device recall Z-0161-2020
xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel)
- FDA Device
- Class II
- ongoing
- Published 2019-10-30
On 2019-10-30 the FDA classified a Class II recall of xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel) by Luminex Molecular Diagnostics, citing the Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0161-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-07-16 |
| Published | 2019-10-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Luminex Molecular Diagnostics |
| Distribution | CA, CT, MA, PA |
Product
xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
Reason
The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.
Identifiers
| code_info | Catalogue Number:I019C0111 Device UDI: 00840487100462 Lot Numbers: IK019C-0129 IK019C-0130 IK019C-0131 IK019C-0132 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0161-2020%22
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