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Recall Observatory FDA recall evidence

Device 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.

Z-0500-2024

November 07, 2023

Class II

Product summary

Firm
Luminex Corporation
Event
Event 93364
Status
Ongoing
Classification
Class II
Quantity
222 kits (4,440 trays)
Official record key
device-enforcement:Z-0500-2024

Official wording

Reason: Potentially defective utility trays in the reagent kits.

Code information: Lot number 062123018C, Exp. 12/20/2023, UDI (01)00840487101674(17)231220(10)062123018C.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potentially defective utility trays in the reagent kits.