Roche Molecular Systems, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0828-2022)

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:

cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190

Product Classification:

Class II

Date Initiated: November 16, 2021

Date Posted: April 6, 2022

Recall Number: Z-0828-2022

Event ID: 89643

Reason for Recall:

Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.

Status: Ongoing

Product Quantity: 14 units

Code Information:

UDI: 07613336100097; Serial Numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, 17086

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of CO, IL, IN, KY, MI, NC, and TX. The countries of Cyprus, Spain, and Hong Kong.

Voluntary or Mandated:

Voluntary: Firm initiated