Verigene nucleic acid test kits recalled for rare false-negative results
Luminex Corporation recalls Verigene nucleic acid test kits that may rarely produce false-negative results due to hydrophobic properties in certain FLOQSwab lots. False-negative results could fail to detect enteric pathogens in patient samples.
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: This is an FDA Class II recall for a diagnostic test that may produce false-negative results, creating risk of missed diagnoses for enteric pathogen infections. No illnesses or injuries have been reported in the source material, making this a theoretical risk-of-harm situation that meets the criterion for a High severity rating.
Plain-English summary
Luminex Corporation is recalling Verigene Enteric Pathogens Nucleic Acid Test kits (Part No. 20-005-023) and Verigene CDF Nucleic Acid Test kits (Part No. 20-005-022). Approximately 3,987 units were distributed worldwide and throughout the United States.
The recalled test kits may, in rare instances, produce false-negative results due to hydrophobic characteristics in certain FLOQSwab lots. A false-negative result occurs when the test fails to detect enteric pathogens that are present in a patient sample, potentially causing missed diagnoses of infections.
Healthcare providers and laboratories using these test kits should review their inventory for the affected lot numbers and consider discontinuing use of recalled units until the issue is resolved.
The recalled product
- Product
- Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
- Manufacturer
- Luminex Corporation
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 3,987
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)
- UDI/DI 00840487101568
- Lot Numbers: 071322023D
- 071822023B
- 071822023C
- 071922023E
- 072022023D
- 072622023D
- 082422023G
- 083022023E
- 083122023E
- 090622023A
- 090822023D
- 091322023D
- 091422023D
- 091422023E
- 092022023E
- 092122023D
- 092722023D
- 092822023D
- 100422023D
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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Similar recalls
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- HighVERIGENE Enteric Pathogens Test may yield false negative results
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