Luminex Verigene Respiratory Pathogens Test Recalled for False-Negative Risk
Luminex Corporation is recalling 38,990 Verigene Respiratory Pathogens Flex nucleic acid tests due to potential false-negative results. The tests were distributed worldwide, including throughout the United States.
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 with no reported illnesses, injuries, or confirmed false-negative incidents. The potential for false-negative results in a diagnostic test poses theoretical clinical risk of missed diagnoses, which does not meet the Severe threshold due to absence of reported actual harm.
Plain-English summary
Luminex Corporation is recalling the Verigene Respiratory Pathogens Flex Nucleic Acid Test (Model Number 20-006-024) due to a potential for false-negative results in test outcomes.
A false-negative result could prevent the detection of respiratory pathogens in patient samples, potentially delaying or missing diagnosis of respiratory infections. This issue affects the reliability of test results in clinical settings.
Approximately 38,990 units were distributed worldwide, including to healthcare facilities throughout the United States (all 50 states plus DC) and internationally to Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and the United Kingdom. Affected lot codes include 030520024A, 030720024A, 031020024A, 031120024A, 031320024A, 031620024C, 031820024A, and numerous others through 091120024A.
Healthcare providers currently using these tests should review the FDA recall notification and contact Luminex Corporation for guidance. Patients who may have received a negative result from one of these tests should consult with their healthcare provider about potential follow-up testing.
The recalled product
- Product
- Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
- Manufacturer
- Luminex Corporation
- Category
- Medical Device — Diagnostic Test
- Affected units
- 38,990
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)
- 030520024A
- 030720024A
- 031020024A
- 031120024A
- 031320024A
- 031620024C
- 031820024A
- 031920024A
- 032120024A
- 032320024A
- 032420024A
- 032620024A
- 033120024A
- 040220024A
- 040320024A
- 040420024A
- 040620024A
- 040720024A
- 040920024A
- 041120024A
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
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