FDA Recalls Luminex Verigene Enteric Pathogen Test Kits for False Positive Results
Luminex Corporation is recalling 4,579 Verigene EP Amplification Reagent Kit Test units worldwide due to potential for false positive results. Affected kits distributed across the United States, Austria, France, Greece, Japan, and Turkey may produce incorrect test results.
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: This is a Class II recall affecting a diagnostic test kit with potential for false positive results—a risk-of-harm product where no illnesses or injuries have been reported. False positive diagnostic results could lead to unnecessary treatment or delayed proper diagnosis, fitting the High (3) classification per the rubric.
Plain-English summary
Luminex Corporation is recalling the Verigene EP Amplification Reagent Kit Test with model name Verigene Enteric Pathogens Stool PREP KIT (Catalog Number 30-002-023), affecting 4,579 units. Multiple lot numbers are included in this Class II recall.
The recall is due to potential for false positive results. These kits may produce false positive test results, which could incorrectly indicate the presence of a pathogen when none is present.
The affected kits have been distributed nationwide throughout the United States and internationally to Austria, France, Greece, Japan, and Turkey.
Healthcare providers and laboratories using these kits should contact Luminex Corporation or the FDA for guidance regarding next steps.
The recalled product
- Product
- Verigene EP Amplification Reagent Kit Test
- Manufacturer
- Luminex Corporation
- Hazard
- false-positive-results
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)
- Model: Verigene Enteric Pathogens (EP) Stool PREP KIT
- Catalog Number: 30-002-023
- Lots: 111620023A 010421023A
- 010621023D
- 010721023E
- 011121023A
- 011221023D
- 011821023A
- 011921023D
- 012521023A
- 012821023D
- 020921023D
- 021021023E
- 021721023D 022221023A
- 030121023A
- 030221023D
- 030221023E
- 030221023F
- 030821023A
- 030921023D
Distribution
Distributed nationwide across the United States.
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