Z-0500-2024 Class II Ongoing
FDA device recall Z-0500-2024 was initiated by Luminex Corporation on November 7, 2023 and is designated Class II. Reason for recall: Potentially defective utility trays in the reagent kits. The recall status is ongoing. Affected quantity: 222 kits (4,440 trays).
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- November 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 222 kits (4,440 trays)
Product 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 for Recall
Potentially defective utility trays in the reagent kits.
Distribution Pattern
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.
Code Information
Lot number 062123018C, Exp. 12/20/2023, UDI (01)00840487101674(17)231220(10)062123018C.