Luminex recalls Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model 20-006-024 due to potential false-negative results. Consumers should check product codes for affected units.
Potential for a false-negative result.
Luminex is recalling a specific model of respiratory pathogen test kit because it may give false-negative results. This means the test might incorrectly show a negative result when the person is actually infected, potentially leading to missed diagnoses.
The test may produce a false-negative result, meaning it could show that a person does not have a respiratory infection when they actually do. This could lead to a missed diagnosis and potential spread of infection if the person is not treated.
People who purchased the Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) model 20-006-024 with the listed serial numbers are affected. Those using the test for respiratory infections are most at risk of missing a diagnosis.
Check the product's model number and serial code on the packaging or label. Affected units have the model number 20-006-024 and specific serial codes listed in the recall notice.
Look for the model number 20-006-024 and the listed serial codes on the test kit packaging or label.
No, the test is safe to use but may give false-negative results, meaning it might miss an infection.
Check the model number and serial code on the packaging. Affected units have model number 20-006-024 and specific serial codes listed in the recall notice.
The recall does not require discarding or returning the test kit. Consumers should check if their kit is affected and be aware of the potential for false-negative results.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2006-2021 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2006-2021 from Luminex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
