FDA Enforcement
Class II
Ongoing
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
Recall: Z-0500-2024
·
Reported December 13, 2023
Enforcement
- Recall Number
- Z-0500-2024
- Event ID
- 93364
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Luminex Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 13, 2023
- Initiation Date
- November 7, 2023
- Classification Date
- December 6, 2023
- Address
- 4088 Commercial Ave, Northbrook, IL, 60062-1829, United States
Description
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
Reason
Potentially defective utility trays in the reagent kits.
Code Info
Lot number 062123018C, Exp. 12/20/2023, UDI (01)00840487101674(17)231220(10)062123018C.
Distribution
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GL, IL, IN, MA, MD, MI, MN, MO, MS, NE, NY, OH, OK, OR, TN, TX, UT, VA, WA, and WI. The country of Italy.
Quantity
222 kits (4,440 trays)