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.
- Company
- Roche Diabetes Care, Inc.
- Recall Initiated
- March 9, 2022
- Terminated
- January 22, 2025
- Recall Number
- Z-1008-2022
- Quantity
- 81 registered accounts
- Firm Location
- Indianapolis, IN
Reason for Recall
Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.
Distribution
US Nationwide Distribution: AK, AZ, CA, CO, DC, FL, GA, IL, IN, MN, NC, NJ, NY, PA, RI, SC, TX, WI
Lot / Code Info
Date of manufacture: 2021-11
Root Cause
Software design
Action Taken
Urgent Medical Device Correction Notice 22-001 was issued March 09, 2022 via email. The software issue was resolved with the cloud-based software update to version 2.5.5 on February 24, 2022. No further action required. Customers to submit notification acknowledgement. Contact your Roche Account Manager or contact Accu-Chek Customer Care at 1-800-628-3346 with questions.
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