Recall Z-0161-2020 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Luminex Molecular Diagnostics
xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
| Date | Jul 16, 2019 |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | An initial Customer Advisory Notice was sent to customers on Jul/16/2019 to advise customers of the firm's potential concerns of false negative results while the firm is conducting its recall investigation. On August 8, 2019, the firm sent to customers via email an "URGENT: MEDICAL DEVICE RECALL/FIELD CORRECTION" Letter to customer which informed its customers of the potential concerns of false negative results and provided them with two options for handling the affected products. The recall letter provided customers with the following options: Option 1: 1. Segregate Recalled Product. Pleas |
| Quantity | 56 Kits |
| Distribution | US distribution to CA, CT, MA, and PA OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081483 | XTAG RESPIRATORY VIRAL PANEL Luminex Molecular Diagnostics, Inc., Jun 25, 2008 |
| K091667 | XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 Luminex Molecular Diagnostics, Inc., Jun 25, 2009 |
| K112199 | XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) Luminex Molecular Diagnostics, Inc., Sep 1, 2011 |
| K112781 | TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I) Luminex Molecular Diagnostics, Inc., Feb 17, 2012 |