Luminex Corporation: Medical Device Recall in 2025 - (Recall #: Z-1903-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test

Product Classification:

Class II

Date Initiated: April 16, 2025

Date Posted: June 11, 2025

Recall Number: Z-1903-2025

Event ID: 96701

Reason for Recall:

It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.

Status: Completed

Product Quantity: 89 units

Code Information:

UDI/DI 00840487101599, Lot Number 022525021A, exp. 08/26/2025

Distribution Pattern:

US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.

Voluntary or Mandated:

Voluntary: Firm initiated