FDA recall Z-2498-2021

Roche Molecular Systems, Inc. · Class II · device

Product

cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190

Reason for recall

Customers have reported an increased number of false positive SARS-CoV-2 results.

Distribution

Worldwide distribution - US Nationwide distribution in the states of AR, CA, IL, IN, KS, ME, MI, MN, MO, NY, OR, TN, TX, WA, and WI. The countries of Canada, UK, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Slovakia, and Spain.

Key facts

Status: Terminated
Initiation date: 2021-08-04
Report date: 2021-09-29
Termination date: 2024-02-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Branchburg, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2498-2021