Recall Z-0161-2020— Luminex Molecular Diagnostics
Class II · Ongoing
Class II FDA medical device recall by Luminex Molecular Diagnostics, initiated 2019-07-16. It names 4 FDA 510(k) clearances: K112781, K112199, K091667 and 1 more. 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..
- Recalling firm
- Luminex Molecular Diagnostics
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-07-16
- Firm location
- Toronto, Canada
510(k) clearances named in this recall
4 on FDA's record- K112781 — TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)
- K112199 — XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
- K091667 — XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116
- K081483 — XTAG RESPIRATORY VIRAL PANEL
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.