Home / Recalls / Luminex Corporation / Z-1334-2022

Z-1334-2022 Class II Ongoing

Recalled by Luminex Corporation — Northbrook, IL

Recall Details

Product Type
Devices
Report Date
July 13, 2022
Initiation Date
June 17, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
296 units

Product Description

Verigene CDF Nucleic Acid Test, Part No. 30-002-22

Reason for Recall

There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.

Code Information

UDI 00840487101735 Luminex Lot Number 042021022D, FLOQ Swab Lot Numbers: 2100856, 2032870; Luminex Lot Number 071321022F, FLOQ Swab Lot Numbers: 2100856, 2107946; Luminex Lot Number 100421022A, FLOQ Swab Lot Numbers: 2110850; Luminex Lot Number 110221022E, FLOQ Swab Lot Numbers: 2107946.

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-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)