The Recall Desk

Manufacturer

Luminex Corporation

39 recalls in our database name Luminex Corporation as the manufacturing or recalling firm.

What the numbers show

Total
39
Critical
0
Severe
0
Most recent
2025-06-11

Of the 39 recalls from Luminex Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–39 of 39

  • HighFDA (Devices)·Z-2775-2020·2020-08-19

    Luminex Verigene Processor SP Recalled for Potential False Negative Results

    Luminex is recalling Verigene Processor SP systems because an instrument failure may cause false negative results for Gram-positive and Gram-negative blood culture tests.

    Product
    Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2776-2020·2020-08-19

    Luminex Verigene Processor SP Recalled for Potential False Negative Results

    Luminex is recalling Verigene Processor SP systems because an instrument failure may cause false negative results in blood culture tests.

    Product
    Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2019·2019-08-28

    Luminex Aries M1 Barcode Scanner Recall for Sample Mismatch Risk

    Luminex is recalling Aries M1 barcode scanners due to incorrect control boards that could cause patient sample mismatches or duplicate results.

    Product
    Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2019·2019-08-21

    Luminex ARIES Flu A/B & RSV Assay Recalled for Seal Defects

    Luminex is recalling ARIES Flu A/B & RSV Assay kits because a seal defect may reduce assay sensitivity or stability.

    Product
    ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2285-2019·2019-08-21

    Luminex ARIES GBS Assay Recalled for Partially Sealed Side Cassettes

    Luminex Corporation is recalling ARIES GBS Assay kits because partially sealed side cassettes may cause decreased assay sensitivity or stability.

    Product
    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2287-2019·2019-08-21

    Luminex Recalls ARIES C. difficile Assay Due to Seal Defects

    Luminex is recalling ARIES C. difficile Assay kits because defective side cassette seals may reduce assay sensitivity and stability.

    Product
    ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-2288-2019·2019-08-21

    Luminex ARIES Extraction Kit Recalled for Partially Sealed Cassette Assemblies

    Luminex Corporation is recalling ARIES Extraction Kits because partially sealed side cassette assemblies may reduce assay sensitivity and stability.

    Product
    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-2286-2019·2019-08-21

    Luminex ARIES Group A Strep Assay Recalled for Seal Defects

    Luminex is recalling ARIES Group A Strep Assay kits because side cassette seals may not meet specifications, potentially affecting test sensitivity and stability.

    Product
    ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-2283-2019·2019-08-21

    Luminex ARIES HSV 1&2 Assay Recalled for Seal Defects

    Luminex is recalling ARIES HSV 1&2 Assay kits because side cassette seals did not meet specifications, potentially affecting test sensitivity and stability.

    Product
    ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
    Category
    Medical Device
    Distribution
    34 states
  • LowFDA (Devices)·Z-0822-2019·2019-02-20

    Luminex Recalls Verigene BC-GP Utility Kits Due to Labeling Error

    Luminex Corporation is recalling Verigene BC-GP Utility Kits because they were incorrectly labeled with Amplification Tray labels.

    Product
    Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identif
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0445-2019·2018-11-21

    Luminex Recalls Verigene Blood Culture Gram-Positive Nucleic Acid Kits

    Luminex Corporation is recalling 12,700 trays of Verigene Blood Culture Gram-Positive Nucleic Acid Kits due to a potential for false negative results.

    Product
    VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2952-2018·2018-09-05

    Luminex Recalls Verigene Enteric Pathogens Test Cartridges Due to False Positives

    Luminex is recalling Verigene Enteric Pathogens Nucleic Acid Test Cartridges because they may produce elevated false positive results for Yersinia enterocolitica.

    Product
    Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointesti
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2094-2017·2017-05-24

    Luminex ARIES System Recalled for Barcode Scanner Data Error

    Luminex Corporation is recalling 15 ARIES Systems because a barcode scanner accessory may incorrectly populate patient sample IDs with previously scanned data.

    Product
    ARIES System and ARIES M1 System
    Category
    Medical Device
    Distribution
    0 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Luminex

biotech company based in Austin, Texas

Country
United States
Founded
1995
Parent company
DiaSorin

Official website

Source: Wikidata (Q6703279), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.