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Luminex Corporation recalls Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a c
Recalled December 13, 2023 · FDA recall Z-0500-2024 · Luminex
Hazard
Potentially defective utility trays in the reagent kits. · FDA Class II
Units
222 kits (4,440 trays)
Sold at
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.
Description
Potentially defective utility trays in the reagent kits.
Product
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.
Manufacturer(s)
Luminex Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →