Home / Recalls / Luminex Corporation / Z-1092-2022

Z-1092-2022 Class II Ongoing

Recalled by Luminex Corporation — Austin, TX

Recall Details

Product Type
Devices
Report Date
May 25, 2022
Initiation Date
April 5, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24 units

Product Description

Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

Reason for Recall

Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

Distribution Pattern

US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None

Code Information

Serial Numbers for 10-0000-07: 17340003 19044007 20133004 18128002 18214004 12061048 18191010 13193254 13051068 21029902 16277059 19233005 11250096 14069051 18255003 *18039010 *20212006 *19317004 *19206009 *18057008 Serial Numbers added 6.23.22 for 10-0000-07R: 18191010 13051068 14069051 *12198198 *12278344 *14322267 *12271338 Serial Numbers added 7.14.22 for 10-0000-07R: 18226007 and 16242043 Serial Numbers added 7.14.22 for 10-0000-07: 17062030, 18235008 and 19192006

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-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-1109-2022 Class II — VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 (February 15, 2022)