The Recall Desk
HighFDA (Devices)·Z-0042-2025·Announced 2024-10-16

Respiratory Pathogen Panel Recalled Due to False Positive Results

The NxTAG Respiratory Pathogen Panel is recalled due to false positive results for human metapneumovirus in about 7.6% of samples, especially those positive for other respiratory pathogens.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with a functional defect that may produce false positive results in 7.6% of samples. Although no illnesses or injuries have been reported, this is a risk-of-harm product where clinical misdiagnosis could occur. The rubric classifies risk-of-harm products without reported injury as High (Score 3).

Plain-English summary

The NxTAG Respiratory Pathogen Panel (REF: I051C0447), a diagnostic test manufactured by Luminex Molecular Diagnostics Inc, is being recalled due to a functional defect that may produce false positive results.

The test may report elevated rates of non-specific human metapneumovirus (hMPV) results with a predicted probability of 7.6%, leading to erroneous co-infection diagnoses. This risk is identified predominantly in clinical samples that test positive for other respiratory pathogens.

The affected product was distributed nationwide to healthcare facilities in the following states: Ohio, California, North Carolina, Wisconsin, Tennessee, Texas, Michigan, New York, Missouri, Florida, Massachusetts, New Jersey, Pennsylvania, Virginia, Arizona, Illinois, Oklahoma, Colorado, and Minnesota. A total of 3,375 units are affected.

Clinical laboratories and healthcare facilities using the affected lot numbers should discontinue use and contact Luminex Molecular Diagnostics Inc for replacement units or further instructions. Affected lot numbers include IK051C-0181 through IK051C-0197 with expirations ranging from September 2024 through December 2024.

The recalled product

Product
NxTAG Respiratory Pathogen Panel, REF: I051C0447
Manufacturer
Luminex Molecular Diagnostics Inc
Category
Medical Device — Respiratory Diagnostic Test
Hazard
  • false-positive-results
  • misdiagnosis

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • UDI-DI: 00840487100417. Lot/Expiration: IK051C-0181/ 9/30/2024
  • IK051C-0182/ 9/30/2024
  • IK051C-0185/ 9/30/2024
  • IK051C-0186/ 9/30/2024
  • IK051C-0187/ 10/31/2024
  • IK051C-0188/ 10/31/2024
  • IK051C-0189/ 10/31/2024
  • IK051C-0190/ 10/31/2024
  • IK051C-0191/ 10/31/2024
  • IK051C-0192/ 10/31/2024
  • IK051C-0193/ 10/31/2024
  • IK051C-0194/ 10/31/2024
  • IK051C-0195/ 10/31/2024
  • IK051C-0196/ 11/30/2024
  • IK051C-0197/ 12/31/2024

Distribution

Distributed nationwide across the United States.

Related recalls

Same category