Luminex recalls Verigene Gram-Positive Blood Culture Nucleic Acid Test (Model 20-006-018) due to potential false-negative results. Affected units sold from 2020-03-06 to 2020-09-01.
Potential for a false-negative result.
Luminex is recalling Verigene Gram-Positive Blood Culture Nucleic Acid Test kits (model 20-006-018) because they might give false-negative results. This could lead to incorrect diagnoses of infections, which is serious for patients needing timely treatment.
The test might produce false-negative results, meaning it could incorrectly show no infection when one is present. This could delay proper treatment for infections that require antibiotics. The risk is specific to the test's accuracy in detecting certain bacterial infections.
Healthcare providers and labs using the Verigene BC-GP test kits with model numbers listed in the recall are affected. Patients receiving results from these kits may be at risk of incorrect infection diagnoses.
Check the model number on the test kit, which includes codes like 030620018A through 090120018A. These units were sold between March 2020 and September 2020.
Look for the model number on the test kit, which should be one of the listed codes (e.g., 030620018A through 090120018A).
The recall is for potential false-negative results, which could lead to incorrect diagnoses of infections and delayed treatment.
Model numbers 030620018A through 090120018A (specifically listed in the recall notice).
No action is required beyond checking the model number. The recall does not require stopping use immediately.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2007-2021 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2007-2021 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.
