Roche Diagnostics Corporation: CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;

Recall number

Z-0360-2019

Recalling firm

Roche Diagnostics Corporation

Product

CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;

Status

Terminated

Initiated

2018-09-13

Posted

2018-11-02

Terminated

2020-10-16

Reason

Abnormally high INR test results with the affected CoaguChek test strips

Root cause

Nonconforming Material/Component

Action

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

Quantity

1,163,952 boxes

Distribution

Nationwide

Lot, serial or model codes

1) Catalog Number 04625375160 Lot Numbers authorized for use within the USA:  28124111 28124121 28631911 28631921 28631924 28632021 28632213 28632312 28632412 29415113 29415123 29494221 29494312 29494613 29494711 29778721 29779012 29779213 29779214 30497213 30497311 30497413 30497423 30497515 31404314 31404821 32264116 32264212 32264316 32264317 32264411 32264421 33045913 33046011 33046113 33046312 33046314 33046321 33046322 33449612 33449712 33449723 33449817   2) Catalog Number 04625374160 Lot Numbers authorized for use within the USA:  28124111 28124121 28631911 28631921 28631924 28632021 28632213 28632312 28632412 29415113 29415123 29494221 29494312 29494613 29494711 29778721 29779012 29779213 29779214 30497213 30497311 30497413 30497423 30497515 31404314 31404821 32264116 32264212 32264316 32264317 32264411 32264421 33045913 33046011 33046113 33046312 33046314 33046321 33046322 33449612 33449712 33449723 33449817  3) Catalog Number: 07797826160 Lot Numbers authorized for use within the USA:  28124111 28124121 28631911 28631921 28631924 28632021 28632213 28632312 28632412 29415113 29415123 29494221 29494312 29494613 29494711 29778721 29779012 29779213 29779214 30497213 30497311 30497413 30497423 30497515 31404314 31404821 32264116 32264212 32264316 32264317 32264411 32264421 33045913 33046011 33046113 33046312 33046314 33046321 33046322 33449612 33449712 33449723 33449817

510(k) numbers

["K071041","K093460","K170960","K180684"]

PMA numbers

not on file

Product code

GJS

Firm FEI

1823260

Firm city

Indianapolis

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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