Recall Z-0043-2025 ยท QLT Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
Luminex Molecular Diagnostics Inc
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
| Date | Oct 9, 2024 (initiated Sep 5, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | On 9/5/24, recall notices were sent to customers and distributors were were asked to do the following: 1. Two options are available to overcome the sporadic potential risk of the hMPV false positive result: A. Continue to use the product as per its instruction for use: in case of a positive result for hMPV, consider performing confirmatory testing with another method before reporting the hMPV result, if medically indicated. B. Exclude the hMPV from the reporting by removing this target from the assay analysis, as explained in the package insert under the chapter "Define Test Panels in SYNCT So |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.