Luminex Recalls
39 recalls on record · May 24, 2017 to June 11, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 11, 2025Medical DevicesFDA
Luminex Corporation recalls VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIG
Hazard: 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.
August 14, 2024Medical DevicesFDA
Luminex Corporation recalls Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Hazard: Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
December 13, 2023Medical DevicesFDA
Luminex Corporation recalls Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a c
Hazard: Potentially defective utility trays in the reagent kits.
July 5, 2023Medical DevicesFDA
Luminex Corporation recalls VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Hazard: It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
July 5, 2023Medical DevicesFDA
Luminex Corporation recalls Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Hazard: It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
November 2, 2022Medical DevicesFDA
Luminex Corporation recalls ARIES SARS-CoV-2 Assay, REF: 50-10047
Hazard: 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.
August 24, 2022Medical DevicesFDA
Luminex Corporation recalls ARIES SARS-CoV-2 Assay
Hazard: SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.
July 13, 2022Medical DevicesFDA
Luminex Corporation recalls VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
Hazard: 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.
July 13, 2022Medical DevicesFDA
Luminex Corporation recalls Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Hazard: 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.
May 25, 2022Medical DevicesFDA
Luminex Corporation recalls VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Hazard: Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
May 25, 2022Medical DevicesFDA
Luminex Corporation recalls Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Hazard: Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
April 20, 2022Medical DevicesFDA
Luminex Corporation recalls Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Hazard: Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
February 9, 2022Medical DevicesFDA
Luminex Corporation recalls ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Hazard: Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.
January 26, 2022Medical DevicesFDA
Luminex Corporation recalls ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Hazard: Impacted lot may leak inside the ARIES instrument.
September 22, 2021Medical DevicesFDA
Luminex Corporation recalls Verigene EP Amplification Reagent Kit Test
Hazard: There is potential for false positive results.
July 14, 2021Medical DevicesFDA
Luminex Corporation recalls Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
Hazard: Potential for a false-negative result.
July 14, 2021Medical DevicesFDA
Luminex Corporation recalls Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
Hazard: Potential for a false-negative result.
July 14, 2021Medical DevicesFDA
Luminex Corporation recalls Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Hazard: Potential for a false-negative result.
July 14, 2021Medical DevicesFDA
Luminex Corporation recalls Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
Hazard: Potential for a false-negative result.
July 14, 2021Medical DevicesFDA
Luminex Corporation recalls Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
Hazard: Potential for a false-negative result.
July 14, 2021Medical DevicesFDA
Luminex Corporation recalls Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Hazard: Potential for a false-negative result.
May 5, 2021Medical DevicesFDA
Luminex Corporation recalls VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle
Hazard: Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
December 2, 2020Medical DevicesFDA
Luminex Corporation recalls Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood
Hazard: Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENE SP devices.
December 2, 2020Medical DevicesFDA
Luminex Corporation recalls Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood
Hazard: Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENESP devices.
October 14, 2020Medical DevicesFDA
Luminex Corporation recalls VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucl
Hazard: No results/incorrect results due to failure of the hybridization heater.
August 19, 2020Medical DevicesFDA
Luminex Corporation recalls Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product U
Hazard: An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
August 19, 2020Medical DevicesFDA
Luminex Corporation recalls Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product U
Hazard: An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
August 28, 2019Medical DevicesFDA
Luminex Corporation recalls Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories
Hazard: An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient order.
August 21, 2019Medical DevicesFDA
Luminex Corporation recalls ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
Hazard: Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
August 21, 2019Medical DevicesFDA
Luminex Corporation recalls ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
Hazard: Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.