Luminex Corporation: Medical Device Recall in 2020 - (Recall #: Z-0054-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

Product Classification:

Class II

Date Initiated: December 10, 2018

Date Posted: October 14, 2020

Recall Number: Z-0054-2021

Event ID: 86358

Reason for Recall:

No results/incorrect results due to failure of the hybridization heater.

Status: Ongoing

Product Quantity: 1 system

Code Information:

Catalogue Number: 10-0000-07 Serial No. 14230205 UDI Code: 00857573006010

Distribution Pattern:

US distribution in MO. No OUS

Voluntary or Mandated:

Voluntary: Firm initiated