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Recall Observatory FDA recall evidence

Device 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.

Z-1008-2022

March 09, 2022

Class II

Product summary

Firm
Roche Diabetes Care, Inc.
Event
Event 89898
Status
Terminated
Classification
Class II
Quantity
81 registered accounts
Official record key
device-enforcement:Z-1008-2022

Official wording

Reason: Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.

Code information: Date of manufacture: 2021-11

Distribution pattern: US Nationwide Distribution: AK, AZ, CA, CO, DC, FL, GA, IL, IN, MN, NC, NJ, NY, PA, RI, SC, TX, WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.