—#184912

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

FDA product code: GJS — Test, Time, Prothrombin
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K060978
Affected lot / code info: All serial numbers

Why it was recalled

Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2020-12-02
Posted by FDA: 2021-01-07
Terminated: 2022-06-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184912. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.