FDA-Device2021-01-13Class II
CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001
Roche Diagnostics Operations, Inc.
Hazard
Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results
Sold states
US Nationwide
Affected count
716,880 units
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0804-2021Don't want to check this manually?
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