Roche Molecular Systems, Inc. recalls cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
- Recall date
- August 4, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2498-2021
- FDA classification
- Class II
- Brand / firm
- Roche Molecular Systems, Inc.
- Sold / distributed
- 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.
Why it was recalled
Customers have reported an increased number of false positive SARS-CoV-2 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 SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
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