CLASS II Device recall · Reported 13 Jan 2021 · FDA Enforcement Report
CoaguChek XS Prof (Professional) Meters- IVD professional recalled
Roche Diagnostics Operations is recalling CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers 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
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-0803-2021
- 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
- Patient Monitors
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 Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 count (i.e. 48 strips)* *CoaguChek XS 3x48 promo LTC HH Catalog: 06298176001 CoaguChek XS 6x24 promo LTC HH Catalog:08468699001 CoaguChek XS 4x48 promo Catalog: 08468745001 CoaguChek XS 6x48 promo Catalog: 08468753001
Where it was distributed
US 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 86951This product is part of a recall event; the main page for the event is CoaguChek XS PST Meters- IVD recalled by Roche Diagnostics Operations.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | CoaguChek XS PST Meters- IVD recalled by Roche Diagnostics Operations | Roche Diagnostics Operations | Other | Nationwide |
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