Home / Recalls / Luminex Corporation / Z-0134-2023

Z-0134-2023 Class II Ongoing

Recalled by Luminex Corporation — Austin, TX

Recall Details

Product Type: Devices
Report Date: November 2, 2022
Initiation Date: September 14, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,141 (24 Cassettes)

Product Description

ARIES SARS-CoV-2 Assay, REF: 50-10047

Reason for Recall

A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.

Distribution Pattern

Distribution US nationwide, Indonesia, and Hong Kong.

Code Information

Lot - Expiration: AB4723A - 05/25/2022, AB5041A - 05/25/2022, AB5060A - 06/01/2022, AB5061A - 06/06/2022, AB5081A - 06/07/2022, AB5139A - 09/10/2022, AB5141A - 09/16/2022, AB5263A - 09/27/2022, AB5282A - 10/05/2022, AB6640A - 06/8/2023, AB6720A - 06/13/2023

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-1524-2022 Class II — ARIES SARS-CoV-2 Assay (July 14, 2022)
Z-1334-2022 Class II — Verigene CDF Nucleic Acid Test, Part No. 30-002-22 (June 17, 2022)
Z-1335-2022 Class II — VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23 (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)
Z-1109-2022 Class II — VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 (February 15, 2022)