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Class 2 Device Recall Roche Diabetes Care Platform |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
March 09, 2022 |
Create Date |
April 26, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1008-2022 |
Recall Event ID |
89898 |
Product Classification |
Calculator/data processing module, for clinical use - Product Code JQP
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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
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Manufacturer Reason for Recall |
Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.
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FDA Determined Cause 2 |
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
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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.
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