Luminex Corporation
Austin, TX
This page shows every FDA and USDA recall linked to Luminex Corporation. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
21
Total Recalls
2011
First Recall
2022
Most Recent
ARIES SARS-CoV-2 Assay, REF: 50-10047
Oct 26, 2022
· Device
Active
ARIES SARS-CoV-2 Assay
Jul 14, 2022
· Device
Active
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
May 13, 2022
· Device
Active
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Nov 17, 2021
· Device
Terminated
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Apr 16, 2021
· Device
Terminated
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD -...
Jun 15, 2020
· Device
Terminated
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD -...
Jun 15, 2020
· Device
Terminated
Luminex Aries M1 System
Model: Aries M6V1
Aries Software v1.0
For In Vitro Diagnostic Use in clinical labor...
Aug 19, 2019
· Device
Terminated
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
Aug 15, 2019
· Device
Active
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
Aug 15, 2019
· Device
Active
ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
Aug 15, 2019
· Device
Active
ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
Aug 15, 2019
· Device
Active
ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
Aug 15, 2019
· Device
Active
ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
Aug 15, 2019
· Device
Active
Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
Aug 15, 2019
· Device
Active
Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018
The Verigene(R) Gram-Positive Blood Culture Nucleic...
Feb 11, 2019
· Device
Terminated
VERIGENE Processor SP
Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identi...
Dec 10, 2018
· Device
Active
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits
(packaged as five-pack carriers)
Product Usage:
In vi...
Nov 10, 2018
· Device
Terminated
Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bact...
May 8, 2018
· Device
Terminated
ARIES System and ARIES M1 System
Apr 19, 2017
· Device
Terminated
xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439 Univers...
Aug 31, 2011
· Device
Terminated