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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Luminex Corporation: Verigene Gram Positive Blood Culture Test Recalled for False Positive Results

Agency Publication Date: August 8, 2024
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Summary

Luminex Corporation is recalling approximately 1,100 kits of the Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test due to defective test cartridges. These cartridges may produce false positive results for Staphylococcus lugdunensis and Enterococcus faecium, which are bacteria that can cause serious infections. This test is used in clinical settings to identify pathogens in blood samples, and incorrect results could lead to inappropriate medical treatment. Consumers and healthcare providers should check their inventory for affected lot number 031824018A and contact the manufacturer or their healthcare provider for further guidance.

Risk

Defective cartridges can report the presence of specific bacteria even when they are not in the patient's blood, potentially leading doctors to prescribe unnecessary or incorrect antibiotics, which can cause side effects or delay the correct diagnosis.

What You Should Do

  1. Identify if you have the affected Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test by checking the packaging for Catalog Number 20-006-018 and GTIN Number 00840487101575.
  2. Specifically check for Lot Number 031824018A with an Expiration Date of 09/16/2024.
  3. If you have an affected test kit, stop using it immediately and contact Luminex Corporation for further instructions on returning or replacing the defective cartridges.
  4. If you are a patient and believe you were tested with this product, contact your healthcare provider to discuss your results and treatment plan.
  5. For additional questions, contact Luminex Corporation or reach out to the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Model / REF:
20-006-018
UPC Codes:
00840487101575
Lot Numbers:
031824018A
Date Ranges: 09/16/2024 (Expiration Date)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94970
Status: Active
Manufacturer: Luminex Corporation
Sold By: Clinical laboratories; Hospitals
Manufactured In: United States
Units Affected: 1,100 kits
Distributed To: Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, Nevada, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.