FDA-Device2021-09-29Class II
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Roche Molecular Systems, Inc.
Hazard
Customers have reported an increased number of false positive SARS-CoV-2 results.
Sold states
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.
Affected count
211 kits (US); 3073 kits (OUS)
Manufactured in
1080 US Highway 202 S, Branchburg, NJ, United States
Products
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2498-2021Don't want to check this manually?
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