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U.S. Department of Health and Human Services

Class 2 Device Recall CoaguChek XS System

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  Class 2 Device Recall CoaguChek XS System see related information
Date Initiated by Firm December 02, 2020
Date Posted January 07, 2021
Recall Status1 Terminated 3 on June 30, 2022
Recall Number Z-0803-2021
Recall Event ID 86951
510(K)Number K060978  
Product Classification Test, time, prothrombin - Product Code GJS
Product 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
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Customer Support Center
317-521-4343
Manufacturer 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
FDA Determined
Cause 2		 Device Design
Action Roche issued on 12/2/2020, UMDC letter notifications via UPS Ground (signature required upon receipt) to Healthcare Professionals, Distributors and Patients provides instructions to users for ensuring the meter is displaying INR results as follows: For the CoaguChek XS Pro system: UMDC for Healthcare Professionals (TP-01147); UMDC TP-01150 (Distributors), including an enclosed UMDC for Healthcare Professionals (TP-01147). For the CoaguChek XS PST system: UMDC for IDTFs (TP-01148) Including an enclosed UMDC for Patients (TP-01142);" UMDC for Clinics (TP-01149);o Including an enclosed UMDC for Patients (TP-01142). The UMDCs posted to the diagnostics.roche.com website. Distributors of CoaguChek Products are instructed as follows: " Read the enclosed Healthcare Professionals UMDC TP-01147 " Within 14 days from receipt of this UMDC distribute a copy of the enclosed Healthcare Professionals UMDC TP-01147 to all customers to whom you have shipped test strips to use with the Coaguchek XS Professional meter within the last 2 years. " If your organization is contractually authorized by Roche to ship test strips to use with the CoaguChek XS Professional meter to redistributors, then your organization must immediately send a copy of this Distributor UMDC TP-01150 and a copy of the enclosed Healthcare Professional UMDC TP-01147 to those re-distributor customers upon your receipt of this UMDC. Such redistributors should take each of the steps included in this Actions Required section of this Distributor UMDC with respect to their own healthcare professional customers. " Complete all sections of the enclosed fax back form (TP-01153); fax or email it according to the instructions on the form. " File this Urgent Medical Device Correction (UMDC) and the enclosed Healthcare Professional UMDC (TP-01147) for future " Healthcare Professionals (HCPs) considered direct government customers (i.e. VA, other government accounts) " If testing a patients INR at your f
Quantity in Commerce 212,093 units
Distribution US Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GJS and Original Applicant = Roche Diagnostics
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