Roche Diagnostics Operations, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0803-2021)

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 Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 count (i.e. 48 strips)* *CoaguChek XS 3x48 promo LTC HH Catalog: 06298176001 CoaguChek XS 6x24 promo LTC HH Catalog:08468699001 CoaguChek XS 4x48 promo Catalog: 08468745001 CoaguChek XS 6x48 promo Catalog: 08468753001

Product Classification:

Class II

Date Initiated: December 2, 2020

Date Posted: January 13, 2021

Recall Number: Z-0803-2021

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: 212,093 units

Code Information:

All serial numbers

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated