Luminex recalls VERIGENE Processor SP Model 10-0000-07 due to potential incorrect test results from hybridization heater failure. Affected units may need repair or replacement.
No results/incorrect results due to failure of the hybridization heater.
Luminex is recalling its VERIGENE Processor SP Model 10-0000-07 because the hybridization heater can fail, causing no results or incorrect test results. This affects lab users who rely on this device for nucleic acid testing.
The hybridization heater in the device can fail, leading to no test results or incorrect results. This happens because the heater doesn't properly heat the sample during the diagnostic process, which is critical for accurate nucleic acid identification.
Lab users who own or use the VERIGENE Processor SP Model 10-0000-07 for nucleic acid testing are most at risk. The recall applies to units sold with Serial No. 14230205 and UDI Code 00857573006010.
Check for the model number 10-0000-07 on the device. Affected units have Serial No. 14230205 or UDI Code 00857573006010.
Look for the model number 10-0000-07 on the device label.
Reach out to Luminex Corporation for guidance on next steps.
The model number is 10-0000-07.
Check for Serial No. 14230205 or UDI Code 00857573006010 on the device.
Contact Luminex Corporation for guidance on next steps.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-0054-2021 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-0054-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
