Luminex Corporation: Medical Device Recall in 2022 - (Recall #: Z-1524-2022)

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:

ARIES SARS-CoV-2 Assay

Product Classification:

Class II

Date Initiated: July 14, 2022

Date Posted: August 24, 2022

Recall Number: Z-1524-2022

Event ID: 90698

Reason for Recall:

SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.

Status: Ongoing

Product Quantity: 257

Code Information:

Lot: AB4042A

Distribution Pattern:

U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.

Voluntary or Mandated:

Voluntary: Firm initiated