Lower riskMedical device recall · FDA · Published June 29, 2018
Luminex Aries M1 System Software v1.0 Recall: Risk of Patient Sample Mismatch
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 Aries M1 System Software v1.0 Recall: Risk of Patient Sample Mismatch.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70695-luminex-aries-m1-system-software-v1-0-recall-risk-of. Based on FDA recall #Z-2292-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2292-2019%22&limit=1).
The FDA announced on June 29, 2018, that Luminex Corporation is recalling the Aries M1 System (Model Aries M6V1) with Aries Software v1.0 due to an incorrect control board and firmware. This defect could result in sample or patient mismatches and duplicate results for patient orders.
How to tell if you have it
Brand: Luminex
Product: Aries M1 System
Model: Aries M6V1
Software: Aries Software v1.0
Scanner Label: JADAK JDK-2330 REV B 170512-017
ARIES System UDI: 00840487101537
ARIES M1 System UDI: 00840487100080
Part Numbers: ARIES-M12V1-IVD, ARIES-M6V1-IVD, CN-0321-01
Date: All scanners manufactured after April 2017
The hazard
According to the FDA, an incorrect control board and firmware installed in some Hand Held Barcode Scanners could result in sample or patient mismatch or duplicate results from other patients' specimens for a patient order.
Context
GovInfoNow's records show Luminex Corporation has 22 other recalls on record since May 8, 2018. Recent recalls include the April 16, 2025 VERIGENE Gram Negative Blood Culture Test Recall for false negative risk and the June 20, 2024 Verigene Gram Positive Blood Culture Test Recall for false positive risk. Other recent recalls of similar products include the Siemens LUMINOS Q.namix R X-Ray System Recall (Dec. 29, 2025) and the GE Healthcare Enterprise Archive V8 Software Recall (July 31, 2026).
How to tell if you have this one
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.
Brand
Luminex
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your Aries M1 System scanner. If it shows v1.0, it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution. US nationwide, Canada, Ireland, Netherlands, Singapore, Thailand, and United Kingdom” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2292-2019 (June 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2292-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.