Food, drugs, devices › Luminex Corporation
Device recall: Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Luminex Corporation (Northbrook, IL) initiated this device recall on 5 Jun 2023; FDA lists 2 product records under event 92451, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Luminex Corporation has 24 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Luminex Corporation, Northbrook, IL.
Reason for recall
"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."
Distribution
"Worldwide and US Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2023-2023 | Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 | 3987 units | Class II | Ongoing | 5 Jul 2023 |
| Z-2024-2023 | VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 | 114 units | Class II | Ongoing | 5 Jul 2023 |
Context
Other enforcement events for Luminex Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 16 Apr 2025 | VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIG | Device | Class II | 1 |
| 20 Jun 2024 | Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test | Device | Class II | 1 |
| 7 Nov 2023 | Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a c | Device | Class II | 1 |
| 14 Sep 2022 | ARIES SARS-CoV-2 Assay, REF: 50-10047 | Device | Class II | 1 |
| 14 Jul 2022 | ARIES SARS-CoV-2 Assay | Device | Class II | 1 |
| 17 Jun 2022 | Verigene CDF Nucleic Acid Test, Part No. 30-002-22 | Device | Class II | 2 |
| 5 Apr 2022 | Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system | Device | Class II | 1 |
| 15 Feb 2022 | VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 | Device | Class II | 1 |
| 17 Nov 2021 | ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 | Device | Class II | 1 |
| 3 Aug 2021 | Verigene EP Amplification Reagent Kit Test | Device | Class II | 1 |
All 24 events for Luminex Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide and US Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.