Luminex recalls Verigene Processor SP models 10-0000-07 and 10-0000-07R used with Gram-Positive Blood tests due to unapproved test fixtures causing calibration errors. Affected units have specific serial numbers listed in the recall.
Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENESP devices.
Luminex is recalling Verigene Processor SP models 10-0000-07 and 10-0000-07R that were used with Gram-Positive Blood tests. The recall is because field service engineers used unapproved test fixtures to calibrate these devices, which could lead to inaccurate test results.
The recall involves test fixtures used by field service engineers that were procured from unapproved sources and sometimes manufactured with unvalidated processes. These fixtures were used to calibrate and verify the Verigene SP devices, which could lead to inaccurate test results if not properly calibrated.
Users of the Verigene Processor SP models 10-0000-07 and 10-0000-07R with Gram-Positive Blood tests are affected. Laboratory technicians who service these devices are most at risk due to potential calibration errors.
Check if your Verigene Processor SP has model numbers 10-0000-07 or 10-0000-07R. The specific serial numbers listed in the recall document indicate affected units.
Verify your device has model numbers 10-0000-07 or 10-0000-07R and matches the listed serial numbers in the recall.
Luminex determined that field service engineers used unapproved test fixtures to calibrate the Verigene SP devices, which could lead to inaccurate test results.
If your device matches the model and serial numbers listed, you should check the recall details to see if action is needed. The recall does not specify a remedy.
The risk is potential inaccurate test results due to improper calibration from unapproved test fixtures, but the recall does not indicate a safety hazard like injury.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-0476-2021 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-0476-2021 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.
