Luminex Corporation: Device Recall

Recall #Z-2533-2024 · 06/20/2024

Class II: Risk

Recall Details

Recall Number: Z-2533-2024
Classification: Class II
Product Type: Device
Recalling Firm: Luminex Corporation
Status: Ongoing
Date Initiated: 06/20/2024
Location: Northbrook, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,100 kits

Reason for Recall

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

Product Description

Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

Distribution Pattern

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.

Other Recalls by Luminex Corporation

Class II: Risk 04/16/2025

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.

View all recalls by Luminex Corporation →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.