| Date Initiated by Firm |
July 16, 2019 |
| Create Date |
October 18, 2019 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0161-2020 |
| Recall Event ID |
83472 |
| 510(K)Number |
K081483 K091667 K112781 K112199
|
| Product Classification |
Respiratory virus panel nucleic acid assay system - Product Code OCC
|
| Product |
xTAG Respiratory Viral Panel (RVP):
Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111
in vitro diagnostic test |
| Code Information |
Catalogue Number:I019C0111 Device UDI: 00840487100462 Lot Numbers: IK019C-0129 IK019C-0130 IK019C-0131 IK019C-0132 |
Recalling Firm/
Manufacturer |
Luminex Molecular Diagnostics
439 University Ave Suite 900
Toronto Canada
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
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. 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 (support@luminexcorp.com) 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 (support@luminexcorp.com) or mail, following the directions on t |
| Quantity in Commerce |
56 Kits |
| Distribution |
US distribution to CA, CT, MA, and PA
OUS: None |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = OCC and Original Applicant = LUMINEX MOLECULAR DIAGNOSTICS, INC.
|
