Home / Recalls / Luminex Corporation / Z-1903-2025

Z-1903-2025 Class II

Recalled by Luminex Corporation — Northbrook, IL

Recall Details

Product Type
Devices
Report Date
June 11, 2025
Initiation Date
April 16, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
89 units

Product Description

VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test

Reason for Recall

It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.

Distribution Pattern

US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.

Code Information

UDI/DI 00840487101599, Lot Number 022525021A, exp. 08/26/2025

Other recalls by Luminex Corporation

  • 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-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)