Luminex Corporation: Medical Device Recall in 2018 - (Recall #: Z-0445-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.

Product Classification:

Class II

Date Initiated: September 14, 2018

Date Posted: November 21, 2018

Recall Number: Z-0445-2019

Event ID: 81220

Reason for Recall:

Potential to lead to a false negative results.

Status: Terminated

Product Quantity: 12,700 trays

Code Information:

Supplier raw tray lots 195916-070518 and 190943-073118 Utility Tray Lots: 082518018C, 081618018C, 082918018C, 090418018B, 081118018C and 082718018B

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of United States - AZ, CA, CO, CT, DC, FL, GA,, IA, ID, IN, KA,, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NV, NJ, NY, OK,,OH, OR, PA, SC, TN, TX, UT, VT, WA, KS, and VA.. France

Voluntary or Mandated:

Voluntary: Firm initiated