Luminex recalls Verigene Processor SP models 10-0000-07/10-0000-07R due to potential false negative results from temperature issues in the Verigene system.
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
Luminex is recalling specific models of the Verigene Processor SP because the heater might not stay within proper temperature limits, which could cause false negative results in tests. This means the device might give incorrect test results if used without the recall fix.
The heater in the Verigene system may operate outside the required temperature range during testing. This can cause the device to produce false negative results, meaning tests might show a negative result when the condition is actually present.
Users of the Verigene system with the recalled processor models are affected. Those performing medical tests with this device are most at risk of incorrect results.
Check for the model numbers 10-0000-07 or 10-0000-07R on the device. The serial numbers listed in the recall notice are specific to the affected units.
Identify the model number on the device to see if it matches 10-0000-07 or 10-0000-07R.
Reach out to Luminex Corporation for assistance with the recall process or to confirm if your device is affected.
The heater in the Verigene system may be outside the established temperature limits for assays, which could lead to false negative results in tests.
Using the recalled processor models might result in false negative results, meaning tests could show a negative outcome when the condition is actually present.
Check the model number on the device; affected models are 10-0000-07 or 10-0000-07R with specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-1092-2022 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-1092-2022 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.
