Roche Diagnostics Operations, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0804-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 2, 2020

Date Posted: January 13, 2021

Recall Number: Z-0804-2021

Event ID: 86951

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

Status: Terminated

Product Quantity: 716,880 units

Code Information:

All serial numbers

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated