Device product

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

Z-2292-2019

June 29, 2018

Class II

Product summary

Firm: Luminex Corporation
Event: Event 81420
Status: Terminated
Classification: Class II
Quantity: 153 (140 U.S. and 13 O.U.S.)
Official record key: device-enforcement:Z-2292-2019

Official wording

Reason: 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.

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

Derived failure modes

Device software or design
reason.device_software_design · v1.0.0

incorrect control board and firmware