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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 Blood Culture Utility Trays Recalled for Potential Defects

Agency Publication Date: December 6, 2023
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Summary

Luminex Corporation is recalling approximately 222 kits (4,440 utility trays) of the Verigene BC-GP Gram-Positive Blood Culture Nucleic Acid Test. These kits, used in clinical settings to detect bacterial infections in blood, contain potentially defective utility trays that may compromise the testing process. Consumers who have these specific kits should immediately identify affected lot numbers and contact the manufacturer or their healthcare provider for guidance.

Risk

Defects in the utility trays can lead to inaccurate or failed test results when diagnosing blood infections. This may delay proper medical treatment for patients with serious gram-positive bacterial infections, potentially leading to worsened health outcomes.

What You Should Do

  1. Check your inventory for the Luminex VERIGENE BC-GP Utility Kit (REF 20-012-018) or the individual 5-Pack Carrier Utility Trays (REF 20-011-018).
  2. Look for Lot number 062123018C with an Expiration Date of 12/20/2023 and UDI (01)00840487101674(17)231220(10)062123018C.
  3. If you identify affected trays, immediately contact your healthcare provider or Luminex Corporation for further instructions and potential product replacement or refund.
  4. Contact Luminex Corporation directly at their headquarters at 4088 Commercial Ave, Northbrook, Illinois, 60062-1829, or via their official support channels.
  5. For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for guidance

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

Affected Products

Product: Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test
Model / REF:
REF 20-011-018
REF 20-012-018
Lot Numbers:
062123018C (Exp. 12/20/2023)
Date Ranges: December 20, 2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93364
Status: Active
Manufacturer: Luminex Corporation
Sold By: Authorized Luminex Distributors
Manufactured In: United States
Units Affected: 222 kits (4,440 trays)
Distributed To: Arizona, California, Colorado, Delaware, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oklahoma, Oregon, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin

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.