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xTAG Respiratory Viral Panel (RVP) recallZ-0161-2020 · Luminex Molecular Diagnostics · initiated Jul 16, 2019

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Luminex Molecular Diagnostics or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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

Recall details

Recall number
Z-0161-2020
Status
Open, Classified
Initiated by the company
Jul 16, 2019
Recalling firm
Luminex Molecular Diagnostics
Quantity
56 Kits
Product code
OCC
FDA submissions
K081483, K091667, K112199, K112781
Distribution
US distribution to CA, CT, MA, and PA OUS: None

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page