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.
What this means for you
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
- false-negative
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
Distributed nationwide across the United States.
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