Luminex recalls Verigene Processor SP models 10-0000-07 and 10-0000-07-R due to repeated No Call results. Affected units have specific serial numbers listed in the recall notice.
Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
Luminex is recalling Verigene Processor SP devices with model numbers 10-0000-07 and 10-0000-07-R because customers report getting no results from these devices. This issue could affect lab testing accuracy and requires attention to ensure proper results.
The processor may repeatedly show 'No Call' results, meaning it fails to communicate with the testing system. This could lead to incorrect test outcomes if the device is used in medical labs without proper troubleshooting.
Lab users who own or operate the Verigene Processor SP models 10-0000-07 and 10-0000-07-R are likely affected. Those performing medical testing with these devices face the highest risk of inaccurate results.
Check for model numbers 10-0000-07 or 10-0000-07-R on the device. Affected units have specific serial numbers listed in the recall notice: 13042054, 16347082, 17215010 for model 10-0000-07 and 18079010 for model 10-0000-07-R.
Verify the model number on your Verigene Processor SP device to see if it matches 10-0000-07 or 10-0000-07-R.
Reach out to Luminex Corporation for guidance on next steps if your device is affected.
The processor may have a software issue causing it to repeatedly show 'No Call' results. This is a known problem with specific model numbers and serial numbers listed in the recall.
Check if your device has model numbers 10-0000-07 or 10-0000-07-R and the specific serial numbers listed in the recall notice.
Contact Luminex Corporation for further instructions. They will provide guidance on resolving the issue.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-0920-2022 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-0920-2022 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.