Luminex Corporation: Medical Device Recall in 2017 - (Recall #: Z-2094-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

ARIES System and ARIES M1 System

Product Classification:

Class II

Date Initiated: April 19, 2017

Date Posted: May 24, 2017

Recall Number: Z-2094-2017

Event ID: 77052

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.

Status: Terminated

Product Quantity: 15 units

Code Information:

ARIES System UDI: 00840487101537 and ARIES M1 System UDI: 00840487100080

Distribution Pattern:

Worldwide Distribution - US Distribution and to the countries of Finland and China.

Voluntary or Mandated:

Voluntary: Firm initiated