Z-2094-2017Class II

ARIES System and ARIES M1 System

Name: Z-2094-2017 ARIES System and ARIES M1 System
Creator: Luminex Corporation
Published: 2017-04-19
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2017-04-19 / Terminated / root cause: manufacturing process

FDA source

Luminex Corporation began a recall of ARIES System and ARIES M1 System on 2017-04-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2094-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-19
Posted: 2017-05-16
Terminated: 2017-10-20
Recalling firm: Luminex Corporation
Product: ARIES System and ARIES M1 System
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 15 units
Distribution: Worldwide Distribution - US Distribution and to the countries of Finland and China.
Product codes and lots: ARIES System UDI: 00840487101537 and ARIES M1 System UDI: 00840487100080

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2094-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2094-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-16

Product code OOI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)