Class 2 Device Recall Roche Diabetes Care Platform

• Date Initiated by Firm: March 09, 2022
• Create Date: April 26, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1008-2022
• Recall Event ID: 89898
• Product Classification: Calculator/data processing module, for clinical use - Product Code JQP
• 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.
• Code Information: Date of manufacture: 2021-11
• Recalling Firm/ Manufacturer: Roche Diabetes Care, Inc.; 9115 Hague Rd; Indianapolis IN 46256-1025
• Manufacturer Reason for Recall: Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.
• FDA Determined Cause: Software design
• Action: 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.
• Quantity in Commerce: 81 registered accounts
• Distribution: US Nationwide Distribution: AK, AZ, CA, CO, DC, FL, GA, IL, IN, MN, NC, NJ, NY, PA, RI, SC, TX, WI
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.