Home / Recalls / Luminex Corporation / Z-2292-2019

Z-2292-2019 Class II Terminated

Recalled by Luminex Corporation — Austin, TX

Recall Details

Product Type
Devices
Report Date
August 28, 2019
Initiation Date
June 29, 2018
Termination Date
April 28, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
153 (140 U.S. and 13 O.U.S.)

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

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.

Distribution Pattern

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

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.

Other recalls by Luminex Corporation

  • Z-1903-2025 Class II — VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; (April 16, 2025)
  • Z-2533-2024 Class II — Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test (June 20, 2024)
  • Z-0500-2024 Class II — Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Cultur (November 7, 2023)
  • Z-2023-2023 Class II — Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 (June 5, 2023)
  • Z-2024-2023 Class II — VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 (June 5, 2023)
  • Z-0134-2023 Class II — ARIES SARS-CoV-2 Assay, REF: 50-10047 (September 14, 2022)
  • Z-1524-2022 Class II — ARIES SARS-CoV-2 Assay (July 14, 2022)
  • Z-1335-2022 Class II — VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23 (June 17, 2022)
  • Z-1334-2022 Class II — Verigene CDF Nucleic Acid Test, Part No. 30-002-22 (June 17, 2022)
  • Z-1092-2022 Class II — Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigen (April 5, 2022)