Luminex recalls Verigene Enteric Pathogens Nucleic Acid Test Model 20-006-023 due to potential false-negative results. Affected units may not detect infections accurately.
Potential for a false-negative result.
Luminex is recalling a specific version of their Verigene Enteric Pathogens Nucleic Acid Test kit because it can give false-negative results. This means the test might incorrectly show a negative result when an infection is actually present, potentially leading to missed diagnoses.
The test may produce false-negative results, meaning it could fail to detect an infection when one is present. This could lead to incorrect conclusions about whether an infection exists, potentially delaying appropriate treatment.
Healthcare professionals using the Verigene Enteric Pathogens Nucleic Acid Test kit for infection screening. Those who have recently purchased the affected model numbers are most at risk of inaccurate test results.
Check the model number on the test kit. Affected units include specific versions labeled 20-006-023 with serial numbers starting with 030420023A through 090920023A.
Look for the model number on the test kit to confirm if it is affected.
The test may produce false-negative results, meaning it could fail to detect an infection when one is present.
Affected model numbers include 20-006-023 with serial numbers starting with 030420023A through 090920023A.
No, but you should check the model number to ensure you have an affected version. If you do, you may want to contact Luminex for guidance.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2009-2021 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2009-2021 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.
