Z-1008-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2022
- Initiation Date
- March 9, 2022
- Termination Date
- January 22, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81 registered accounts
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.
Distribution Pattern
US Nationwide Distribution: AK, AZ, CA, CO, DC, FL, GA, IL, IN, MN, NC, NJ, NY, PA, RI, SC, TX, WI
Code Information
Date of manufacture: 2021-11