Recall Z-1008-2022— Roche Diabetes Care, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Diabetes Care, Inc., initiated 2022-03-09, terminated 2025-01-22. FDA's recall record names no specific 510(k) clearance for this event. Product: RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.. Reason: Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software..
- Recalling firm
- Roche Diabetes Care, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-03-09
- Terminated
- 2025-01-22
- Firm location
- Indianapolis, IN, United States
Product description
RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.
Reason for recall
Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.
Data sourced from openFDA. This site is unofficial and independent of the FDA.