Z-0803-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 13, 2021
- Initiation Date
- December 2, 2020
- Termination Date
- June 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 212,093 units
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
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 Pattern
US Nationwide
Code Information
All serial numbers