ARIES System and ARIES M1 System recallZ-2094-2017 · Luminex Corporation · initiated Apr 19, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Luminex Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument.
FDA root cause category: Nonconforming Material/Component
What the company is doing
A recall notification letter was sent out on April 19, 2017. Prior to the recall letter being sent, the recalling firm sent a Customer Advisory Notification on April 14, 2017. The firm is also adding an accountability form to the customer notifications in order to document the customer responses to ensure that we account for the estimated 15 distributed units. For further questions, please call (877) 785-2323.
Recall details
- Recall number
- Z-2094-2017
- Status
- Terminated
- Initiated by the company
- Apr 19, 2017
- Recalling firm
- Luminex Corporation
- Quantity
- 15 units
- Product code
- OOI
- FDA submissions
- K151917, K160517, K162772
- Distribution
- Worldwide Distribution - US Distribution and to the countries of Finland and China.
Product description
ARIES System and ARIES M1 System
Code information (models, lots, serial numbers)
ARIES System UDI: 00840487101537 and ARIES M1 System UDI: 00840487100080
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- ARIES® M1 System ARIES M6V1Luminex Corporation · real time Nucleic acid amplification system2 recalls0 reports
- ARIES® System ARIES M12V1Luminex Corporation · real time Nucleic acid amplification system2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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