FDA recall Z-0828-2022

Product

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

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.

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2021-11-16

Report date

2022-04-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Branchburg, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0828-2022