Luminex Corporation: Medical Device Recall in 2022 - (Recall #: Z-0920-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R

Product Classification:

Class II

Date Initiated: April 22, 2019

Date Posted: April 20, 2022

Recall Number: Z-0920-2022

Event ID: 89051

Reason for Recall:

Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.

Status: Ongoing

Product Quantity: 4 units

Code Information:

Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010

Distribution Pattern:

US: TX, CT, LA

Voluntary or Mandated:

Voluntary: Firm initiated