Luminex recalls Verigene Processor SP devices with specific serial numbers that may produce false negative results for Gram-positive blood culture tests. Affected units include those with serial numbers listed in the recall notice.
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-positive blood culture tests. This could lead to incorrect test outcomes if the device is used without the recall fix.
The device may produce false negative results for Gram-positive blood culture tests, meaning it could incorrectly indicate a negative result when the bacteria are actually present. This could lead to missed infections if the test is not properly interpreted.
Users of the Verigene Processor SP with specific serial numbers listed in the recall notice. Most at risk are healthcare professionals using the device for blood culture testing.
Check if your Verigene Processor SP has a serial number listed in the provided list (e.g., 902, 907, 908, etc.). The device is used with single-use test kits for blood culture testing.
Verify your device's serial number against the list provided in the recall notice to determine if it is affected.
If your device is affected, contact Luminex Corporation for further instructions on how to handle the device.
The device may produce false negative results for Gram-positive blood culture tests, which could lead to missed infections if the test is not properly interpreted.
Check your device's serial number against the list of affected serial numbers provided in the recall notice.
Contact Luminex Corporation for further instructions on how to handle the device.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2775-2020 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2775-2020 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.
