Recall Z-0804-2021— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-0804-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-02

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2020-12-02, terminated 2022-06-30. It names one FDA 510(k) clearance: K062925. 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: Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results.

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-12-02
Terminated: 2022-06-30
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K062925 — COAGUCHEK XS SYSTEMRoche Diagnostics Corp.·cleared 2007-01-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.