Luminex Corporation: Medical Device Recall in 2022 - (Recall #: Z-1109-2022)

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 Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

Product Classification:

Class II

Date Initiated: February 15, 2022

Date Posted: May 25, 2022

Recall Number: Z-1109-2022

Event ID: 90129

Reason for Recall:

Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.

Status: Ongoing

Product Quantity: 984 units

Code Information:

Lot Number 101321021B

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated