Luminex Corporation: Medical Device Recall in 2019 - (Recall #: Z-0822-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria.

Product Classification:

Class III

Date Initiated: December 26, 2018

Date Posted: February 20, 2019

Recall Number: Z-0822-2019

Event ID: 81890

Reason for Recall:

On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.

Status: Terminated

Product Quantity: 1132 carriers

Code Information:

UDI: 00857573006287, Lots: 110318018C, 111018018D

Distribution Pattern:

Worldwide Distribution: US (nationwide) and countries of: Austria, and Italy.

Voluntary or Mandated:

Voluntary: Firm initiated