Luminex Corporation: Medical Device Recall in 2024 - (Recall #: Z-2533-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

Product Classification:

Class II

Date Initiated: June 20, 2024

Date Posted: August 14, 2024

Recall Number: Z-2533-2024

Event ID: 94970

Reason for Recall:

Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.

Status: Ongoing

Product Quantity: 1,100 kits

Code Information:

GTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024

Distribution Pattern:

US Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, MS, NE, NV, OH, OK, SC, TN, TX, VA, VT, WA, WV.

Voluntary or Mandated:

Voluntary: Firm initiated