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FDA (Device enforcement)Recalled 2023-11-07class ii

Luminex Corporation: 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-

Hazard

Potentially defective utility trays in the reagent kits.

Details from the source

Reason for recall: Potentially defective utility trays in the reagent kits. 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) Lot/code info: Lot number 062123018C, Exp. 12/20/2023, UDI (01)00840487101674(17)231220(10)062123018C.

UPC codes

00840487101674

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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