FDA recall Z-0804-2021

Roche Diagnostics Operations, Inc. · Class II · device

Product

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

Reason for recall

Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results

Distribution

US Nationwide

Key facts

Status: Terminated
Initiation date: 2020-12-02
Report date: 2021-01-13
Termination date: 2022-06-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0804-2021