Luminex Corporation: Medical Device Recall in 2022 - (Recall #: Z-0134-2023)

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:

ARIES SARS-CoV-2 Assay, REF: 50-10047

Product Classification:

Class II

Date Initiated: September 14, 2022

Date Posted: November 2, 2022

Recall Number: Z-0134-2023

Event ID: 90937

Reason for Recall:

A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.

Status: Ongoing

Product Quantity: 5,141 (24 Cassettes)

Code Information:

Lot - Expiration: AB4723A - 05/25/2022, AB5041A - 05/25/2022, AB5060A - 06/01/2022, AB5061A - 06/06/2022, AB5081A - 06/07/2022, AB5139A - 09/10/2022, AB5141A - 09/16/2022, AB5263A - 09/27/2022, AB5282A - 10/05/2022, AB6640A - 06/8/2023, AB6720A - 06/13/2023

Distribution Pattern:

Distribution US nationwide, Indonesia, and Hong Kong.

Voluntary or Mandated:

Voluntary: Firm initiated