Austin, TX, United States
Luminex Corporation recalls
23 recalls recorded since 2018, most recently on 16 April 2025. 14 are listed as ongoing. Status and classification are as published by the FDA.
Recalls23
Ongoing (FDA)14
Terminated or completed9
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 16 April 2025
- Reason
- 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
- US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1903-2025
- 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
Ongoing Class II Medical devices
- Recall started
- 20 June 2024
- Reason
- Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
- Distribution
- US Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, MS, NE, NV, OH, OK, SC, TN, TX, VA, VT, WA, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2533-2024
- Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Ongoing Class II Medical devices
- Recall started
- 7 November 2023
- Reason
- Potentially defective utility trays in the reagent kits.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GL, IL, IN, MA, MD, MI, MN, MO, MS, NE, NY, OH, OK, OR, TN, TX, UT, VA, WA, and WI. The country of Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0500-2024
- Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
Ongoing Class II Medical devices
- Recall started
- 5 June 2023
- Reason
- 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.
- Distribution
- Worldwide and US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2024-2023, Z-2023-2023
- VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
- Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Ongoing Class II Medical devices
- Recall started
- 14 September 2022
- Reason
- 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.
- Distribution
- Distribution US nationwide, Indonesia, and Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0134-2023
- ARIES SARS-CoV-2 Assay, REF: 50-10047
Ongoing Class II Medical devices
- Recall started
- 14 July 2022
- Reason
- 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.
- Distribution
- U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1524-2022
Ongoing Class II Medical devices
- Recall started
- 17 June 2022
- Reason
- 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
- Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1335-2022, Z-1334-2022
- VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
- Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Ongoing Class II Medical devices
- Recall started
- 5 April 2022
- Reason
- Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
- Distribution
- US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1092-2022
- Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Ongoing Class II Medical devices
- Recall started
- 15 February 2022
- Reason
- Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1109-2022
- VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Terminated Class II Medical devices
- Recall started
- 17 November 2021
- Terminated
- 8 July 2024
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of New Jersey, California, Connecticut, Minnesota, Missouri, New Jersey, New Mexico, Pennsylvania, Tennessee, Washington, and Wisconsin) and the country of Malaysia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0553-2022
- ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Ongoing Class II Medical devices
- Recall started
- 3 August 2021
- Reason
- There is potential for false positive results.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2451-2021
- Verigene EP Amplification Reagent Kit Test
Terminated Class II Medical devices
- Recall started
- 16 April 2021
- Terminated
- 20 September 2024
- Reason
- Impacted lot may leak inside the ARIES instrument.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Alabama, California, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, Wisco
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0498-2022
- ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Ongoing Class II Medical devices
- Recall started
- 18 March 2021
- Reason
- 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.
- Distribution
- Worldwide distribution - United States (nationwide) and the countries of Austria, France, Greece, Japan, Netherlands, Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1488-2021
- VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
Ongoing Class II Medical devices
- Recall started
- 30 October 2020
- Reason
- Potential for a false-negative result.
- Distribution
- Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Ja
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2006-2021, Z-2008-2021, Z-2009-2021, Z-2010-2021, Z-2011-2021, Z-2007-2021
- Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
- Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
- Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
- Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
- Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
- Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
Terminated Class II Medical devices
- Recall started
- 13 October 2020
- Terminated
- 22 January 2024
- Reason
- 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.
- Distribution
- Worldwide distribution. US nationwide and Kuwait, Austria, United Kingdom, Spain, France, Chile, Japan, Netherlands, Greece, Italy, Thailand, Germany, Turkey
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0476-2021, Z-0477-2021
- Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single
- Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single
Terminated Class II Medical devices
- Recall started
- 15 June 2020
- Terminated
- 30 June 2023
- Reason
- An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CN, CT, DE, DC, FL,GA, ID, IN, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NB, NV, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN TX, UT, VT, VA, WA, WV, WY, and WI. The countri
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2776-2020, Z-2775-2020
- Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge
- Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge
Ongoing Class II Medical devices
- Recall started
- 22 April 2019
- Reason
- Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
- Distribution
- US: TX, CT, LA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0920-2022
- Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Ongoing Class II Medical devices
- Recall started
- 20 February 2019
- Reason
- 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.
- Distribution
- US: AK, AL, AZ,CA,CO,FL,GA,IL,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,NE,NJ,NM,NY,OH,ON,OR,PA,TN,TX,UT,VA,VT,WA,WI, OUS: Belgium, Canada, Thailand, Germany, Singapore, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2283-2019, Z-2287-2019, Z-2284-2019, Z-2285-2019, Z-2286-2019, Z-2282-2019, Z-2288-2019
- ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
- ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
- ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
- ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
- ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
- Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
- ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
Terminated Class III Medical devices
- Recall started
- 26 December 2018
- Terminated
- 4 August 2020
- Reason
- On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Austria, and Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0822-2019
- Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitr
Ongoing Class II Medical devices
- Recall started
- 10 December 2018
- Reason
- No results/incorrect results due to failure of the hybridization heater.
- Distribution
- US distribution in MO. No OUS
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0054-2021
- VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Terminated Class II Medical devices
- Recall started
- 14 September 2018
- Terminated
- 28 April 2021
- Reason
- Potential to lead to a false negative results.
- Distribution
- Worldwide Distribution - US Nationwide in the states of United States - AZ, CA, CO, CT, DC, FL, GA,, IA, ID, IN, KA,, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NV, NJ, NY, OK,,OH, OR, PA, SC, TN, TX, UT, VT, WA, KS, and VA.. France
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0445-2019
- VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-posit
Terminated Class II Medical devices
- Recall started
- 29 June 2018
- Terminated
- 28 April 2021
- Reason
- 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.
- Distribution
- Worldwide distribution. US nationwide, Canada, Ireland, Netherlands, Singapore, Thailand, and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2292-2019
- Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017
Terminated Class II Medical devices
- Recall started
- 8 May 2018
- Terminated
- 29 June 2020
- Reason
- Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nucleic Acid Test Cartridges component (20-006-023) from the Verigene EP Nucleic Acid Test Kit (20-005-023).
- Distribution
- Domestic Distribution: Arizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New Hampshire, Tennessee, Texas, Utah, West Virginia, Wisconsin.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2952-2018
- Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collect
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.