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Open, Classified

xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test

FDA Recall Z-0161-2020 · Posted None

Recalling FirmLuminex Molecular Diagnostics
Recall StatusOpen, Classified
Product CodeOCC
Date Initiated2019-07-16
Product Quantity56 Kits

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.

Firm 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. Please immediately remove all affects lots from their inventory that are unused and unexpired (regardless of location) and segregate these lots in a secure location for destruction. 2. Complete Acknowledgment and Receipt Form 1. Complete and return the enclosed Acknowledgment and Receipt Form 1 by email ([email protected]) or mail (even if you do not have any product on hand), following the directions on this page and the Acknowledgment and Receipt Form. Global Support Services can assist customers in completing the form, if needed. Please destroy the product and provide confirmation in the Acknowledgment and Receipt Form on or before July xx, 2019. The firm will replace any unused products and handle any customer concerns on a case-by-case basis. Please inform Global Support Services if you destroyed product and need a replacement(s). Option 2: If customer have the affected products and wish to continue using the product for testing, customers are instructed to complete Acknowledgment and Receipt Form 2 which states that customer acknowledged that they will continue using the affected product and will not use the product for testing and reporting results for the Influenza A (H3) and RSV A. Customers are instructed to complete and return the enclosed Acknowledgment and Receipt Form 2 by email ([email protected]) or mail, following the directions on t

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112781TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)Luminex Molecular Diagnostics, Inc. · 2012-02-17K112199XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)Luminex Molecular Diagnostics, Inc. · 2011-09-01K091667XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116Luminex Molecular Diagnostics, Inc. · 2009-06-25K081483XTAG RESPIRATORY VIRAL PANELLuminex Molecular Diagnostics, Inc. · 2008-06-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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