Luminex Corporation: Medical Device Recall in 2022 - (Recall #: Z-1092-2022)

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, Models 10-0000-07/10-0000-07R a component of the Verigene system

Product Classification:

Class II

Date Initiated: April 5, 2022

Date Posted: May 25, 2022

Recall Number: Z-1092-2022

Event ID: 90023

Reason for Recall:

Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

Status: Ongoing

Product Quantity: 24 units

Code Information:

Serial Numbers for 10-0000-07: 17340003 19044007 20133004 18128002 18214004 12061048 18191010 13193254 13051068 21029902 16277059 19233005 11250096 14069051 18255003 *18039010 *20212006 *19317004 *19206009 *18057008 Serial Numbers added 6.23.22 for 10-0000-07R: 18191010 13051068 14069051 *12198198 *12278344 *14322267 *12271338 Serial Numbers added 7.14.22 for 10-0000-07R: 18226007 and 16242043 Serial Numbers added 7.14.22 for 10-0000-07: 17062030, 18235008 and 19192006

Distribution Pattern:

US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated