Luminex Molecular Diagnostics Inc: NxTAG Respiratory Pathogen Panels Recalled for False Positive hMPV Results

Agency Publication Date: October 9, 2024

Summary

Luminex Molecular Diagnostics Inc. has recalled approximately 3,988 units of its NxTAG Respiratory Pathogen Panels, including the version with SARS-CoV-2 testing. These diagnostic kits, used by healthcare facilities to identify respiratory infections, may report an elevated rate of non-specific human Metapneumovirus (hMPV) results. This defect has a 7.6% predicted probability of occurrence, particularly when a clinical sample is already positive for another target, leading to incorrect reports of co-infections. If you have been tested using these specific diagnostic panels between September 2024 and January 2025, you should contact your healthcare provider to discuss your results.

Risk

The device may erroneously report a positive result for human Metapneumovirus (hMPV) when the virus is not actually present. This false positive result can lead to unnecessary treatments, incorrect medical management, or a failure to investigate the true cause of a patient's symptoms.

What You Should Do

Identify if your healthcare facility uses the NxTAG Respiratory Pathogen Panel (REF: I051C0447) with lot numbers IK051C-0181 through IK051C-0197, or the NxTAG Respiratory Pathogen Panel +SARS-CoV-2 (REF: I056C0468) with lot numbers IK056C-0033 through IK056C-0039.
Check the expiration dates on your diagnostic kits, which range from September 30, 2024, to January 31, 2025.
If you are a healthcare provider, immediately review your inventory for the affected lot numbers and contact Luminex Molecular Diagnostics Inc. at 439 University Ave Suite 900, Toronto, Canada, for further instructions regarding affected supplies.
Patients who suspect they were tested with an affected kit and received a positive hMPV result should contact their healthcare provider to determine if re-testing or clinical re-evaluation is necessary.
For additional information, contact Luminex Molecular Diagnostics Inc. or the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Clinical notification and manufacturer coordination.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: NxTAG Respiratory Pathogen Panel

Model / REF:

I051C0447

Lot Numbers:

IK051C-0181 (Exp 9/30/2024)

IK051C-0182 (Exp 9/30/2024)

IK051C-0185 (Exp 9/30/2024)

IK051C-0186 (Exp 9/30/2024)

IK051C-0187 (Exp 10/31/2024)

IK051C-0188 (Exp 10/31/2024)

IK051C-0189 (Exp 10/31/2024)

IK051C-0190 (Exp 10/31/2024)

IK051C-0191 (Exp 10/31/2024)

IK051C-0192 (Exp 10/31/2024)

IK051C-0193 (Exp 10/31/2024)

IK051C-0194 (Exp 10/31/2024)

IK051C-0195 (Exp 10/31/2024)

IK051C-0196 (Exp 11/30/2024)

IK051C-0197 (Exp 12/31/2024)

Date Ranges: 9/30/2024 - 12/31/2024

Product: NxTAG Respiratory Pathogen Panel +SARS-CoV-2

Model / REF:

I056C0468

Lot Numbers:

IK056C-0033 (Exp 9/30/2024)

IK056C-0034 (Exp 10/31/2024)

IK056C-0035 (Exp 10/31/2024)

IK056C-0036 (Exp 12/31/2024)

IK056C-0037 (Exp 12/31/2024)

IK056C-0038 (Exp 12/31/2024)

IK056C-0039 (Exp 1/31/2025)

Date Ranges: 9/30/2024 - 1/31/2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95377

Status: Active

Manufacturer: Luminex Molecular Diagnostics Inc

Sold By: Clinical laboratories; Hospitals; Healthcare facilities

Manufactured In: Canada

Units Affected: 2 products (3375; 613)

Distributed To: Ohio, California, North Carolina, Wisconsin, Tennessee, Texas, Michigan, New York, Missouri, Florida, Massachusetts, New Jersey, Pennsylvania, Virginia, Arizona, Illinois, Oklahoma, Colorado, Minnesota

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your healthcare facility uses the NxTAG Respiratory Pathogen Panel (REF: I051C0447) with lot numbers IK051C-0181 through IK051C-0197, or the NxTAG Respiratory Pathogen Panel +SARS-CoV-2 (REF: I056C0468) with lot numbers IK056C-0033 through IK056C-0039.

Check the expiration dates on your diagnostic kits, which range from September 30, 2024, to January 31, 2025.

If you are a healthcare provider, immediately review your inventory for the affected lot numbers and contact Luminex Molecular Diagnostics Inc. at 439 University Ave Suite 900, Toronto, Canada, for further instructions regarding affected supplies.

Patients who suspect they were tested with an affected kit and received a positive hMPV result should contact their healthcare provider to determine if re-testing or clinical re-evaluation is necessary.

For additional information, contact Luminex Molecular Diagnostics Inc. or the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: NxTAG Respiratory Pathogen Panel

Model / REF:

I051C0447

Lot Numbers:

IK051C-0181 (Exp 9/30/2024)

IK051C-0182 (Exp 9/30/2024)

IK051C-0185 (Exp 9/30/2024)

IK051C-0186 (Exp 9/30/2024)

IK051C-0187 (Exp 10/31/2024)

IK051C-0188 (Exp 10/31/2024)

IK051C-0189 (Exp 10/31/2024)

IK051C-0190 (Exp 10/31/2024)

IK051C-0191 (Exp 10/31/2024)

IK051C-0192 (Exp 10/31/2024)

IK051C-0193 (Exp 10/31/2024)

IK051C-0194 (Exp 10/31/2024)

IK051C-0195 (Exp 10/31/2024)

IK051C-0196 (Exp 11/30/2024)

IK051C-0197 (Exp 12/31/2024)

Date Ranges: 9/30/2024 - 12/31/2024

Product: NxTAG Respiratory Pathogen Panel +SARS-CoV-2

Model / REF:

I056C0468

Lot Numbers:

IK056C-0033 (Exp 9/30/2024)

IK056C-0034 (Exp 10/31/2024)

IK056C-0035 (Exp 10/31/2024)

IK056C-0036 (Exp 12/31/2024)

IK056C-0037 (Exp 12/31/2024)

IK056C-0038 (Exp 12/31/2024)

IK056C-0039 (Exp 1/31/2025)

Date Ranges: 9/30/2024 - 1/31/2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95377

Status: Active

Manufacturer: Luminex Molecular Diagnostics Inc

Sold By: Clinical laboratories; Hospitals; Healthcare facilities

Manufactured In: Canada

Units Affected: 2 products (3375; 613)