FDA-Device2023-12-13Class II
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.
Luminex Corporation
Hazard
Potentially defective utility trays in the reagent kits.
Sold states
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.
Affected count
222 kits (4,440 trays)
Manufactured in
4088 Commercial Ave, Northbrook, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0500-2024Don't want to check this manually?
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