Luminex recalls Verigene Processor SP models 10-0000-07 and 10-0000-07R used with Gram-Negative 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 VERIGENE SP devices.
Luminex is recalling Verigene Processor SP models 10-0000-07 and 10-0000-07R used with Gram-Negative Blood tests because field service engineers used unapproved test fixtures that could lead to calibration errors. This recall affects specific units with listed serial numbers.
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-Negative Blood tests are affected. Laboratory technicians and healthcare facilities using these devices are most at risk due to potential calibration issues.
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. This device is used with Luminex Gram-Negative Blood tests.
Verify your Verigene Processor SP model number is 10-0000-07 or 10-0000-07R.
Check if your device's serial number is listed in the provided serial number list for affected units.
Luminex determined that field service engineers used test fixtures from unapproved sources that were sometimes manufactured with unvalidated processes, which could lead to calibration errors in the Verigene SP devices.
No action is required if your device's serial number is not in the list provided in the recall notice.
The risk is potential calibration errors that could affect test accuracy, but the recall does not indicate a risk of injury or serious harm.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-0477-2021 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-0477-2021 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.
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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.
