Z-0360-2019Class I

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

Name: Z-0360-2019 CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160...
Creator: Roche Diagnostics Corporation
Published: 2018-09-13
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2018-09-13 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Corporation began a recall of CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number... on 2018-09-13. FDA classified it as Class I and gives the reason as "Abnormally high INR test results with the affected CoaguChek test strips". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0360-2019
Classification: Class I
Status: Terminated
Initiated: 2018-09-13
Posted: 2018-11-02
Terminated: 2020-10-16
Recalling firm: Roche Diagnostics GmbH
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;
Product code: GJS Test, Time, Prothrombin
Reason for recall: Abnormally high INR test results with the affected CoaguChek test strips
Root cause tag: manufacturing process
FDA 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 [email protected]. - 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 [email protected]. - 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 in commerce: 1,163,952 boxes
Distribution: Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0360-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0360-2019	Class I	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-02

Product code GJS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)