Home / Recalls / Luminex Molecular Diagnostics / Z-0161-2020

Z-0161-2020 Class II Ongoing

Recalled by Luminex Molecular Diagnostics — Toronto

Recall Details

Product Type
Devices
Report Date
October 30, 2019
Initiation Date
July 16, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
56 Kits

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.

Distribution Pattern

US distribution to CA, CT, MA, and PA OUS: None

Code Information

Catalogue Number:I019C0111 Device UDI: 00840487100462 Lot Numbers: IK019C-0129 IK019C-0130 IK019C-0131 IK019C-0132

Other recalls by Luminex Molecular Diagnostics

  • Z-0043-2025 Class II — NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468 (September 5, 2024)
  • Z-0042-2025 Class II — NxTAG Respiratory Pathogen Panel, REF: I051C0447 (September 5, 2024)
  • Z-1767-2019 Class II — xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative d (February 22, 2019)