Verigene Enteric Pathogens Test May Return False-Negative Results
Luminex Corporation is recalling Verigene Enteric Pathogens diagnostic tests due to potential for false-negative results, which could miss serious bacterial infections.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II diagnostic test with potential for false-negative results in pathogen detection. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Luminex Corporation is recalling Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number 20-006-023, a diagnostic test used in clinical laboratories to detect bacterial pathogens that cause gastrointestinal infections. The FDA classified this as a Class II recall.
The recall is due to the potential for the test to return false-negative results. This means the test may fail to detect infections that are actually present, which could lead to missed diagnoses and delays in appropriate treatment.
A total of 24,338 units have been distributed worldwide, including throughout all U.S. states and multiple countries including Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and the United Kingdom. Healthcare facilities and clinical laboratories using this test may be affected.
Healthcare providers should contact Luminex Corporation for guidance regarding affected lot numbers and review of results obtained with affected units to ensure patient safety.
The recalled product
- Product
- Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
- Manufacturer
- Luminex Corporation
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 24,338
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 030420023A
- 031720023A
- 032520023A
- 040820023B
- 041520023B
- 042220023B
- 042820023A
- 050120023A
- 050620023B
- 050820023B
- 052720023A
- 052820023A
- 060420023A
- 060620023A
- 061120023A
- 061820023A
- 062520023A
- 062720023A
- 070220023A
- 070920023A
Distribution
Part of a larger recall action
This product is one of 6 recalled by Luminex Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Luminex Corporation
See all →- HighLuminex VERIGENE Gram Negative Blood Culture Test Recalled
FDA (Devices) · 2025-06-11
- HighVerigene Gram Positive Blood Culture Test Recalled for Defective Cartridges
FDA (Devices) · 2024-08-14
- ModerateLuminex VERIGENE BC-GP Utility Trays Recalled Due to Potential Defects
FDA (Devices) · 2023-12-13
- HighVerigene nucleic acid test kits recalled for rare false-negative results
FDA (Devices) · 2023-07-05
- HighVERIGENE Clostridium difficile Nucleic Acid Test May Give False-Negative Results
FDA (Devices) · 2023-07-05
Same hazard · false negative
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighHologic Aptima HPV assay may produce invalid or false negative results
FDA (Devices) · 2026-03-25
- HighHeparin antibody test kits recalled over a defect producing negative results
FDA (Drugs) · 2026-01-21
Similar recalls
- HighVerigene nucleic acid test kits recalled for rare false-negative results
FDA (Devices) · 2023-07-05
- HighVERIGENE Enteric Pathogens Test may yield false negative results
FDA (Devices) · 2022-07-13
- ModerateLuminex Recalls Verigene Enteric Pathogens Test Cartridges Due to False Positives
FDA (Devices) · 2018-09-05
- HighFDA Recalls Luminex Verigene Enteric Pathogen Test Kits for False Positive Results
FDA (Devices) · 2021-09-22
- SevereNanosphere Verigene Enteric Pathogens Test Recalled for Processing Errors
FDA (Devices) · 2014-10-01
- HighLuminex VERIGENE Processor SP Recalled for Potential False-Negative Pathogen Results
FDA (Devices) · 2021-05-05