Z-1008-2022 Class II Terminated
FDA device recall Z-1008-2022 was initiated by Roche Diabetes Care, Inc. on Mar 9, 2022 and is designated Class II. Reason for recall: Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software. The recall status is terminated (terminated Jan 22, 2025). Affected quantity: 81 registered accounts.
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2022
- Initiation Date
- Mar 9, 2022
- Termination Date
- Jan 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1008-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026