Luminex recalls Aries M1 System software v1.0 for in vitro diagnostics due to potential patient sample mismatches and duplicate results. Affected units have specific scanner labels and were sold after April 2017.
An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient order.
Luminex is recalling its Aries M1 System software version 1.0 for clinical labs. This software version can cause patient samples to be mismatched or duplicated, which could lead to incorrect test results for patients.
The software version 1.0 has an incorrect control board and firmware that can cause the system to mix up patient samples or produce duplicate results for different patients. This could lead to incorrect test results if the system is used in clinical labs.
Clinical laboratory users with the Aries M1 System software version 1.0 installed on scanners labeled JADAK JDK-2330 REV B 170512-017 or similar. Lab technicians handling patient samples are most at risk.
Check for scanner labels with 'JADAK JDK-2330 REV B 170512-017' or similar. The system was sold after April 2017 and includes specific part numbers like JDK-2330 Rev B.
Verify the software version on your Aries M1 System scanner. If it shows v1.0, it is affected.
The recalled software version is Aries v1.0 for the Aries M1 System.
Look for scanner labels with 'JADAK JDK-2330 REV B 170512-017' or similar. The system was sold after April 2017 and includes specific part numbers like JDK-2330 Rev B.
No immediate stop is required, but you should check the software version and update it if needed.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2292-2019 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2292-2019 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.
