RegWardenFDA facility compliance records
Company

Luminex Corporation

24 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2017: 1 recalls; 2018: 5 recalls; 2019: 2 recalls; 2020: 3 recalls; 2021: 4 recalls; 2022: 5 recalls; 2023: 2 recalls; 2024: 1 recalls; 2025: 1 recalls1201752018220193202042021520222202312024120252026
  • Recalls (24)

Registered facilities (3)

Recalls & enforcement

20251 record
  • Class IICompleted2025-04-16
    It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
20241 record
  • Class IIOngoing2024-06-20
    Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
20232 records
  • Class IIOngoing2023-11-07
    Potentially defective utility trays in the reagent kits.
  • Class IIOngoing2023-06-05
    It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
20225 records
  • Class IIOngoing2022-09-14
    A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.
  • Class IIOngoing2022-07-14
    SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.
  • Class IIOngoing2022-06-17
    There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
  • Class IIOngoing2022-04-05
    Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
  • Class IIOngoing2022-02-15
    Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
20214 records
  • Class IITerminated2021-11-17
    Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.
  • Class IIOngoing2021-08-03
    There is potential for false positive results.
  • Class IITerminated2021-04-16
    Impacted lot may leak inside the ARIES instrument.
  • Class IIOngoing2021-03-18
    Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
20203 records
  • Class IIOngoing2020-10-30
    Potential for a false-negative result.
  • Class IITerminated2020-10-13
    Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate …
  • Class IITerminated2020-06-15
    An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
20192 records
  • Class IIOngoing2019-04-22
    Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
  • Class IIOngoing2019-02-20
    Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume f…
20185 records
  • Class IIITerminated2018-12-26
    On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
  • Class IIOngoing2018-12-10
    No results/incorrect results due to failure of the hybridization heater.
  • Class IITerminated2018-09-14
    Potential to lead to a false negative results.
  • Class IITerminated2018-06-29
    An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient order.
  • Class IITerminated2018-05-08
    Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nucleic Acid Test Cartridges component (20-006-023) from the Verigene EP Nucleic Acid Test Kit (20-005-023).
20171 record
  • Class IITerminated2017-04-19
    The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Luminex Corporation — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9032042-luminex-corporation/

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