The Recall Desk
HighFDA (Devices)·Z-0043-2025·Announced 2024-10-16

Medical Device Recall: Respiratory Panel May Report Incorrect hMPV Results

The NxTAG Respiratory Pathogen Panel may produce false positive results for human Metapneumovirus (hMPV), potentially leading to incorrect co-infection diagnoses.

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: This is an FDA Class II medical device recall with an identified defect in test performance that can produce false positive diagnostic results. No illnesses or injuries have been reported; however, the false positive results constitute a risk of clinical harm through potential misdiagnosis and incorrect patient management decisions.

Plain-English summary

Luminex Molecular Diagnostics Inc is recalling 613 units of the NxTAG Respiratory Pathogen Panel +SARS-CoV-2 (Reference: I056C0468) due to a defect that can produce false positive results for human Metapneumovirus (hMPV).

The affected test panels may report an elevated rate of non-specific hMPV target results, particularly in clinical samples that test positive for another respiratory pathogen. This can lead to an erroneous co-infection result, incorrectly indicating that a patient has both hMPV and another respiratory infection when only one pathogen is actually present.

The recall affects 613 test kits distributed nationwide to healthcare facilities in 19 states: Ohio, California, North Carolina, Wisconsin, Tennessee, Texas, Michigan, New York, Missouri, Florida, Massachusetts, New Jersey, Pennsylvania, Virginia, Arizona, Illinois, Oklahoma, Colorado, and Minnesota. Lot numbers affected are IK056C-0033 through IK056C-0039 with expiration dates ranging from September 2024 through January 2025.

Laboratories and healthcare providers using these test kits should review their results from the affected lots. The FDA classifies this as a Class II recall.

The recalled product

Product
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Manufacturer
Luminex Molecular Diagnostics Inc
Category
Medical Device — Diagnostic Test
Hazard
  • false-positive-diagnostic
  • diagnostic-error

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 (7)

  • Lot/Expiration: IK056C-0033/ 9/30/2024
  • IK056C-0034/ 10/31/2024
  • IK056C-0035/ 10/31/2024
  • IK056C-0036/ 12/31/2024
  • IK056C-0037/ 12/31/2024
  • IK056C-0038/ 12/31/2024
  • IK056C-0039/ 1/31/2025

Distribution

Distributed nationwide across the United States.

Related recalls

Same category