NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Reported: October 16, 2024 Initiated: September 5, 2024 #Z-0043-2025
Product Description
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Reason for Recall
Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.
Details
- Recalling Firm
- Luminex Molecular Diagnostics Inc
- Units Affected
- 613
- Distribution
- U Nationwide distribution in the states of OH, CA, NC, WI, TN, TX, MI, NY, MO, FL, MA, NJ, PA, VA, AZ, IL, OK, CO, MN.
- Location
- Toronto
Frequently Asked Questions
What product was recalled? ▼
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468. Recalled by Luminex Molecular Diagnostics Inc. Units affected: 613.
Why was this product recalled? ▼
Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2024. Severity: Moderate. Recall number: Z-0043-2025.
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