Roche Molecular Systems, Inc. recalls cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190

Recall date

November 16, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0828-2022

FDA classification

Class II

Brand / firm

Roche Molecular Systems, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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