Luminex recalls
13 official recalls and safety alerts involving Luminex since 2022-01, from EU Safety Gate, FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Luminex or the relevant agency.
- 2025-06-11
USLuminex Corporation recalls VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System;…
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.
FDA · DeviceLuminex CorporationUS Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC,…Official notice →- 2025-04-25
PL
EUFixed lamp (LUMINEX) · RENO
A live wire is in contact with the metal casing of the lamp. The user could touch accessible live parts and receive an electric shock. The product does not comply with the requirements of the Low Voltage Directive, nor…
- 2024-08-14
- US
Luminex Corporation recalls Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
FDA · DeviceLuminex CorporationUS Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA,…Official notice → - 2023-12-13
- US
Luminex Corporation recalls Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the…
Potentially defective utility trays in the reagent kits.
FDA · DeviceLuminex CorporationWorldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL,…Official notice → - 2023-07-05
- US
Luminex Corporation recalls VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
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…
- 2022-11-02
- US
Luminex Corporation recalls ARIES SARS-CoV-2 Assay, REF: 50-10047
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.
FDA · DeviceLuminex CorporationDistribution US nationwide, Indonesia, and Hong Kong.Official notice → - 2022-08-24
- US
Luminex Corporation recalls ARIES SARS-CoV-2 Assay
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…
FDA · DeviceLuminex CorporationU.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.Official notice → - 2022-07-13
- US
Luminex Corporation recalls VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
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.
FDA · DeviceLuminex CorporationWorldwide distribution - US Nationwide and the countries of Kuwait, Austria,…Official notice → - 2022-05-25
- US
Luminex Corporation recalls VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
- US
Luminex Corporation recalls Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
FDA · DeviceLuminex CorporationUS:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: NoneOfficial notice → - 2022-04-20
- US
Luminex Corporation recalls Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
- 2022-02-09
- US
Luminex Corporation recalls ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
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.
FDA · DeviceLuminex CorporationWorldwide distribution - US Nationwide distribution in the states of New…Official notice → - 2022-01-26
- US
Luminex Corporation recalls ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Impacted lot may leak inside the ARIES instrument.
FDA · DeviceLuminex CorporationWorldwide distribution - US Nationwide distribution in the states of Alabama,…Official notice →