Device product
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Z-2498-2021
Product summary
- Event
- Event 88600
- Status
- Terminated
- Classification
- Class II
- Quantity
- 211 kits (US); 3073 kits (OUS)
- Official record key
device-enforcement:Z-2498-2021
Official wording
Reason: Customers have reported an increased number of false positive SARS-CoV-2 results.
Code information: Lot 10119Z
Distribution pattern: 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.
Derived failure modes
-
Unknown
Customers have reported an increased number of false positive SARS-CoV-2 results.