Luminex recalls Verig: Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model 20-006-026 due to potential false-negative results. Affected units may not detect infections accurately.
Potential for a false-negative result.
Luminex is recalling its Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model 20-006-026 because it can give false-negative results, meaning infections might not be detected. This could lead to missed diagnoses and treatment delays.
The test may produce false-negative results, meaning it could fail to detect certain infections in blood samples. This risk is specific to the test's performance and does not involve physical harm or immediate danger.
Healthcare providers using this blood test for infection detection are likely affected. Patients relying on this test for accurate diagnosis may be at risk of undetected infections.
Check for the model number 20-006-026 on the test kit. The product was sold with serial numbers 050620026A and 072120026B.
Look for the model number 20-006-026 on the test kit packaging or label.
No, the recall is due to potential false-negative results, not physical harm or injury.
Check for the model number 20-006-026 on the test kit, or serial numbers 050620026A and 072120026B.
The recall does not require immediate action; check the model number to confirm if it's affected.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2011-2021 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2011-2021 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.
