Chrysalis Intelligence · Sponsors · Luminex Corporation

Luminex Corporation

Northbrook, IL, US · 5 510(k) clearances · 25 recalls

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Total clearances
5
2024-03-01 → 2026-05-19
Last 12 months
1
Product codes
5
Most recent
2026-05-19
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System Class II Microbiology 1 2026-05-19
PAM Gram-Positive Bacteria And Their Resistance Markers Class II Microbiology 1 2025-06-06
PEN Gram-Negative Bacteria And Associated Resistance Markers Class II Microbiology 1 2025-04-18
PEO Fungal Organisms, Nucleic Acid-Based Assay Class II Microbiology 1 2024-06-04
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents Class II Microbiology 1 2024-03-01
Safety

Recalls (25)

Class I (serious)
0
Risk of injury / death
Total recalls
25
Currently ongoing
18
Most recent
2025-04-16
DateSeverityStatusRecall # ProductCodeReason
2025-04-16 Class II Completed Z-1903-2025 VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIG… — 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.
2024-06-20 Class II Ongoing Z-2533-2024 Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test — Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
2023-11-07 Class II Ongoing Z-0500-2024 Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a c… — Potentially defective utility trays in the reagent kits.
2023-06-05 Class II Ongoing Z-2024-2023 VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 — 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 (Par…
2023-06-05 Class II Ongoing Z-2023-2023 Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 — 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 (Par…
2022-09-14 Class II Ongoing Z-0134-2023 ARIES SARS-CoV-2 Assay, REF: 50-10047 — 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.
2022-07-14 Class II Ongoing Z-1524-2022 ARIES SARS-CoV-2 Assay — 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 bo…
2022-06-17 Class II Ongoing Z-1335-2022 VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23 — 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.
2022-06-17 Class II Ongoing Z-1334-2022 Verigene CDF Nucleic Acid Test, Part No. 30-002-22 — 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.
2022-04-05 Class II Ongoing Z-1092-2022 Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system — Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
2022-02-15 Class II Ongoing Z-1109-2022 VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 — Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
2021-11-17 Class II Terminated Z-0553-2022 ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 — 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 del…
2021-08-03 Class II Ongoing Z-2451-2021 Verigene EP Amplification Reagent Kit Test — There is potential for false positive results.
2021-04-16 Class II Terminated Z-0498-2022 ARIES HSV 1&2 Assay, Part Number/REF 50-10017 — Impacted lot may leak inside the ARIES instrument.
2021-03-18 Class II Ongoing Z-1488-2021 VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle… — Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Te…
2020-10-30 Class II Ongoing Z-2011-2021 Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026 — Potential for a false-negative result.
2020-10-30 Class II Ongoing Z-2010-2021 Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022 — Potential for a false-negative result.
2020-10-30 Class II Ongoing Z-2009-2021 Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023 — Potential for a false-negative result.
2020-10-30 Class II Ongoing Z-2008-2021 Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021 — Potential for a false-negative result.
2020-10-30 Class II Ongoing Z-2007-2021 Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018 — Potential for a false-negative result.
2020-10-30 Class II Ongoing Z-2006-2021 Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024 — Potential for a false-negative result.
2020-10-13 Class II Terminated Z-0477-2021 Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood … — Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved…
2020-10-13 Class II Terminated Z-0476-2021 Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood… — Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved…
2020-06-15 Class II Terminated Z-2776-2020 Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product U… — An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
2020-06-15 Class II Terminated Z-2775-2020 Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product U… — An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2026-05-19 K253722 LIAISON PLEX Gastrointestinal Flex Assay PCH Class II Microbiology
2025-06-06 K243490 LIAISON PLEX Gram-Positive Blood Culture Assay PAM Class II Microbiology
2025-04-18 K243013 LIAISON PLEX Gram-Negative Blood Culture Assay PEN Class II Microbiology
2024-06-04 K240627 LIAISON PLEX Yeast Blood Culture Assay PEO Class II Microbiology
2024-03-01 K233410 LIAISON PLEX Respiratory Flex Assay QOF Class II Microbiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence