Skip to main content

Is My Product Recalled?

Food Recalls Medication Recalls Baby Products Pet Products Toys Electronics Household Vehicles Medical Devices Other

Scan How It Works Saved Get Alerts

Menu

Search All Recalls Latest Recalls Scan Barcode Get Alerts

Categories

Food Recalls Medication Recalls Baby Products Pet Products Toys Electronics Household Vehicles Medical Devices Other

Resources

How Recalls Work FAQ Recall Classifications Statistics & Trends About

Your Recalls

Loading...

Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

Home
/
Brands
/
Luminex Corporation

Luminex Corporation Recalls

All product recalls associated with Luminex Corporation.

Get alerts for this brand

Recall Summary

Total Recalls

18

Past Year

0

Class I (Serious)

0

Most Recent

Jun 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–18 of 18 recalls

Luminex Corporation: Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid...

Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.

FDAJun 20, 2024Nationwide• Luminex Corporation

Luminex Corporation: Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gra...

Potentially defective utility trays in the reagent kits.

FDANov 7, 2023Nationwide• Luminex Corporation

Luminex Corporation: Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30...

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.

FDA

Jun 5, 2023

Nationwide

• Luminex Corporation

Luminex Corporation: VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-...

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.

FDAJun 5, 2023Nationwide• Luminex Corporation

Luminex Corporation: 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.

FDASep 14, 2022Nationwide• Luminex Corporation

Luminex Corporation: 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 result would be generated.

FDAJul 14, 2022Nationwide• Luminex Corporation

Luminex Corporation: VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30...

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.

FDAJun 17, 2022Nationwide• Luminex Corporation

Luminex Corporation: Verigene CDF Nucleic Acid Test, Part No. 30-002-22

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.

FDAJun 17, 2022Nationwide• Luminex Corporation

Luminex Corporation: Verigene Processor SP, Models 10-0000-07/10-0000-07R a c...

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

FDAApr 5, 2022AZ, CA, CO +13 more• Luminex Corporation

Luminex Corporation: VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9....

Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.

FDAFeb 15, 2022Nationwide• Luminex Corporation

Luminex Corporation: Verigene EP Amplification Reagent Kit Test

There is potential for false positive results.

FDAAug 3, 2021Nationwide• Luminex Corporation

Luminex Corporation: VERIGENE Processor SP - Product Usage: intended for proce...

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.

FDAMar 18, 2021Nationwide• Luminex Corporation

Luminex Corporation: Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP...

Potential for a false-negative result.

FDAOct 30, 2020Nationwide• Luminex Corporation

Luminex Corporation: Verigene Clostridium difficile Nucleic Acid Test Kit (CDF...

Potential for a false-negative result.

FDAOct 30, 2020Nationwide• Luminex Corporation

Luminex Corporation: Verigene Gram Negative Blood Culture Nucleic Acid Test (B...

Potential for a false-negative result.

FDAOct 30, 2020Nationwide• Luminex Corporation

Luminex Corporation: Verigene Enteric Pathogens Nucleic Acid Test (EP) Model N...

Potential for a false-negative result.

FDAOct 30, 2020Nationwide• Luminex Corporation

Luminex Corporation: Verigene Gram-Positive Blood Culture Nucleic Acid Test (B...

Potential for a false-negative result.

FDAOct 30, 2020Nationwide• Luminex Corporation

Luminex Corporation: Verigene Processor SP, Model Numbers: 10-0000-07 and 10-...

Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.

FDAApr 22, 2019CT, LA, TX• Luminex Corporation