CLASS II Device recall · Reported 13 Jan 2021 · FDA Enforcement Report

CoaguChek XS PST Meters- IVD recalled by Roche Diagnostics Operations

Roche Diagnostics Operations is recalling CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for, distributed nationwide in the US. The recall was initiated on 2 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers

Quantity recalled716,880 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0804-2021
FDA event ID: 86951
Recalling firm: Roche Diagnostics Operations, Indianapolis, IN
Classification: Class II
Status: Terminated
Recall initiated: 2 Dec 2020
FDA classified: 7 Jan 2021
Reported: 13 Jan 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Dec 2020	Recall initiated by company
7 Jan 2021	Classified by FDA	+36 days
13 Jan 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

US Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results

Which lots are affected?

All serial numbers

Where was it sold?

US Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 86951

Reported	Class	Recall	Company	Reason	Where
13 Jan 2021	CLASS II	CoaguChek XS Prof (Professional) Meters- IVD professional recalled	Roche Diagnostics Operations	Other	Nationwide

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