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Roche Molecular Systems, Inc. recalls cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Recalled September 29, 2021 · FDA recall Z-2498-2021 · Roche Molecular Systems
Hazard
Customers have reported an increased number of false positive SARS-CoV-2 results. · FDA Class II
Units
211 kits (US); 3073 kits (OUS)
Sold at
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.
Description
Customers have reported an increased number of false positive SARS-CoV-2 results.
Product
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Manufacturer(s)
Roche Molecular Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →