CoaguChek XS System Prothrombin time test recallZ-0360-2019 · Roche Diagnostics Corporation · initiated Sep 13, 2018
Class I Terminated All recalls posted in November 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Abnormally high INR test results with the affected CoaguChek test strips
FDA root cause category: Nonconforming Material/Component
What the company is doing
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
Recall details
- Recall number
- Z-0360-2019
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Sep 13, 2018
- Posted by the FDA
- Nov 2, 2018
- Recalling firm
- Roche Diagnostics Corporation
- Quantity
- 1,163,952 boxes
- Product code
- GJS
- FDA submissions
- K071041, K093460, K170960, K180684
- Distribution
- Nationwide
Product description
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;
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Other devices under the same FDA submission
3 devices cleared under K071041, K093460, K170960, K180684 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CoaguChek Vantus System 07729952160Roche Diagnostics GmbH · Test, Time, Prothrombin24 reports
- CoaguChek XS Plus Professional Care Kit 04562780001Roche Diagnostics GmbH · Test, Time, Prothrombin3 reports
- CoaguChek XS Pro Kit 5530199160Roche Diagnostics GmbH · TEST, TIME, PROTHROMBIN1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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