Toronto, Canada
Luminex Molecular Diagnostics recalls
3 recalls recorded since 2018, most recently on 5 September 2024. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 September 2024
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0043-2025, Z-0042-2025
- NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
- NxTAG Respiratory Pathogen Panel, REF: I051C0447
Ongoing Class II Medical devices
- Recall started
- 16 July 2019
- Reason
- The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.
- Distribution
- US distribution to CA, CT, MA, and PA OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0161-2020
- xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
Ongoing Class II Medical devices
- Recall started
- 22 February 2019
- Reason
- Reports have been received of lower MS2 MFI values when using the panel.
- Distribution
- Distribution from the firm's Austin, Texas, location was made to AL, AR, AZ, CA, FL, GA, IL, IN, MO, NC, ND, NJ, NY, OK, TN, TX, VA, and WI. There was military distribution but no government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1767-2019
- xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IV
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.