xTAG Respiratory Viral Panel — Class II medical device recall Z-0161-2020
Ongoing recall by Luminex Molecular Diagnostics, reported 2019-10-30, distributed in CA, CT, MA, PA. The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A i
| Recall number | Z-0161-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Molecular Diagnostics, Toronto, Canada |
| Recall initiated | 2019-07-16 |
| Classified | 2019-10-18 |
| Reported by FDA | 2019-10-30 |
| Distributed | CA, CT, MA, PA |
| Quantity | 56 kits |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00840487100462 |
| Lot numbers | IK019C-0129, IK019C-0130, IK019C-0131, IK019C-0132 |
| Model numbers | I019C0111 |
Product
xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0161-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.