FDA-Device2022-05-04Class II
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.
Roche Diabetes Care, Inc.
Hazard
Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.
Sold states
US Nationwide Distribution: AK, AZ, CA, CO, DC, FL, GA, IL, IN, MN, NC, NJ, NY, PA, RI, SC, TX, WI
Affected count
81 registered accounts
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2022Don't want to check this manually?
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