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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 613
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
Part of a larger recall action
This product is one of 2 recalled by Luminex Molecular Diagnostics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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