FDA Enforcement
Class II
Ongoing
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Recall: Z-2533-2024
·
Reported August 14, 2024
Enforcement
- Recall Number
- Z-2533-2024
- Event ID
- 94970
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Luminex Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- August 14, 2024
- Initiation Date
- June 20, 2024
- Classification Date
- August 8, 2024
- Address
- 4088 Commercial Ave, Northbrook, IL, 60062-1829, United States
Description
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Reason
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
Code Info
GTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024
Distribution
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.
Quantity
1,100 kits