Z-0804-2021Class II

CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking...

Name: Z-0804-2021 CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking...
Creator: Roche Diagnostics Operations, Inc.
Published: 2020-12-02
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2020-12-02 / Terminated / root cause: design

FDA source

Roche Diagnostics Operations, Inc. began a recall of CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or... on 2020-12-02. FDA classified it as Class II and gives the reason as "Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0804-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-02
Posted: 2021-01-07
Terminated: 2022-06-30
Recalling firm: Roche Diagnostics GmbH
Product: CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001
Product code: GJS Test, Time, Prothrombin
Reason for recall: 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 tag: design
FDA root cause: Device Design
Action: 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
Quantity in commerce: 716,880 units
Distribution: US Nationwide
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0804-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0803-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0804-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07

Product code GJS

K062925Class IICoaguchek Xs SystemRoche Diagnostics Corp. / cleared 2007-01-29

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)