Home / Recalls / Luminex Corporation / Z-2094-2017

Z-2094-2017 Class II Terminated

Recalled by Luminex Corporation — Austin, TX

Recall Details

Product Type
Devices
Report Date
May 24, 2017
Initiation Date
April 19, 2017
Termination Date
October 20, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15 units

Product Description

ARIES System and ARIES M1 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.

Distribution Pattern

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

Code Information

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

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)