Z-0161-2020Class II

xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111...

Name: Z-0161-2020 xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111...
Creator: Luminex Molecular Diagnostics
Published: 2019-07-16
License: https://open.fda.gov/license/

Luminex Molecular Diagnostics Inc / initiated 2019-07-16 / Open, Classified / root cause: design

FDA source

Luminex Molecular Diagnostics began a recall of xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test on 2019-07-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0161-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-07-16
Posted: 2019-10-18
Recalling firm: Luminex Molecular Diagnostics Inc
Product: xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
Product code: OCC Respiratory Virus Panel Nucleic Acid Assay System
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.
Root cause tag: design
FDA 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. 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
Quantity in commerce: 56 Kits
Distribution: US distribution to CA, CT, MA, and PA OUS: None
Product codes and lots: Catalogue Number:I019C0111 Device UDI: 00840487100462 Lot Numbers: IK019C-0129 IK019C-0130 IK019C-0131 IK019C-0132

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0161-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0161-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-10-30	2019-10-18

Product code OCC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)