Luminex recalls Verigene Processor SP devices with specific serial numbers that may produce false negative results for Gram-Negative Blood Culture tests, potentially leading to missed infections. Affected units include those with serial numbers listed in the recall.
An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
Luminex is recalling Verigene Processor SP devices that may give false negative results for Gram-Negative Blood Culture tests, which could lead to missed infections. This recall affects specific units with serial numbers listed in the notice.
The device may fail to correctly identify Gram-Negative bacteria in blood cultures, resulting in false negative test results. This could lead to missed infections if the device does not detect bacteria that are present.
Healthcare facilities using Verigene Processor SP devices for blood culture testing may be affected. Patients receiving blood culture tests could be at risk if the device produces false negatives, but the risk is not immediate or severe.
Check if your Verigene Processor SP device has a serial number listed in the provided list of affected serial numbers (e.g., 902, 907, 908, etc.). The device uses single-use test consumables and self-contained test cartridges for each sample.
Verify if your Verigene Processor SP has a serial number listed in the provided list of affected serial numbers.
Reach out to Luminex Corporation for further assistance or to confirm if your device is affected.
The device may produce false negative results for Gram-Negative Blood Culture tests, which could lead to missed infections. However, the risk is not immediate or severe.
Check if your Verigene Processor SP has a serial number listed in the provided list of affected serial numbers.
No, the recall does not require immediate discontinuation of use. Affected units should be checked and contacted for further instructions.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2776-2020 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2776-2020 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.
