Luminex Corporation: Medical Device Recall in 2019 - (Recall #: Z-2292-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

Product Classification:

Class II

Date Initiated: June 29, 2018

Date Posted: August 28, 2019

Recall Number: Z-2292-2019

Event ID: 81420

Reason for Recall:

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.

Status: Terminated

Product Quantity: 153 (140 U.S. and 13 O.U.S.)

Code Information:

ARIES System UDI: 00840487101537 ARIES M1 System UDI: 00840487100080 ARIES-M12V1-IVD, ARIES System ARIES-M6V1-IVD, ARIES M1 System CN-0321-01, ARIES System Handheld Barcode Scanner All scanners manufactured after April 2017 and including Part Number JDK-2330 Rev B.

Distribution Pattern:

Worldwide distribution. US nationwide, Canada, Ireland, Netherlands, Singapore, Thailand, and United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated