CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS P

FDA device recall Z-0360-2019 · posted 2018-11-02 · Terminated

Recall details

Recalling firm

Roche Diagnostics Corporation

Reason for recall

Abnormally high INR test results with the affected CoaguChek test strips

Action taken

Roche issued URGENT MEDICAL DEVICE RECALL AMENDMENT letters dated 11/5/18 advising customers patients, HCPs, IDTFs, HCP distributors and HCP/patient distributors. Distributors are advised to take the following actions: - Read the Urgent Medical Device Recall Amendment for Healthcare Professionals and Clinics Furnishing PT/INR Test Strips to Patients for Home Testing Use (TP-00454). - Distribute a copy of the Urgent Medical Device Recall Amendment TP-00454 to healthcare professionals to whom you have directly shipped affected test strips. - Stop distribution of all affected CoaguChek XS PT Test Strip lots. - Complete all sections of the fax form (TP-00462) and fax it to number 1-888-627-2279 or email it to roche3866@stericycle.com. - Return all affected product following the instructions outlined in this Urgent Medical Device Recall Amendment. Independent Diagnostic Testing Facilities should take the following action: - Read the Urgent Medical Device Recall Amendment for CoaguChek Patients (TP-00453) and Urgent Medical Device Recall Amendment for Healthcare Professionals and Clinics Furnishing PT/INR Test Strips to Patients for Home Testing Use (TP-00454). - Distribute a copy of the Urgent Medical Device Recall Amendment for CoaguChek Patients (TP-00453) to your CoaguChek patient self-testers. - Distribute a copy of the Urgent Medical Device Recall Amendment for Healthcare Professionals and Clinics Furnishing PT/INR Test Strips to Patients for Home Testing Use (TP-00454) to your Healthcare Professional customers. - Stop distribution of all affected CoaguChek XS PT Test Strip lots. - Complete all sections of the fax form (TP-00461) and fax it to number 1-888-627-2279 or email it to roche3866@stericycle.com. - Return all affected product following the instructions outlined in the Urgent Medical Device Recall Amendment. Healthcare Professionals and Clinics Furnishing test strips to Patients for Home Use should take the following action: - Stop usin

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GJS

Quantity affected

1,163,952 boxes

Distribution

Nationwide

Date initiated

2018-09-13

Date posted

2018-11-02

Date terminated

2020-10-16

Location

Indianapolis, IN

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