Luminex Corporation: Medical Device Recall in 2023 - (Recall #: Z-0500-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 7, 2023

Date Posted: December 13, 2023

Recall Number: Z-0500-2024

Event ID: 93364

Reason for Recall:

Potentially defective utility trays in the reagent kits.

Status: Ongoing

Product Quantity: 222 kits (4,440 trays)

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.

Voluntary or Mandated:

Voluntary: Firm initiated