Roche Diabetes Care, Inc. recalls RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software host…
- Recall date
- March 9, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1008-2022
- FDA classification
- Class II
- Brand / firm
- Roche Diabetes Care, Inc.
- Sold / distributed
- US Nationwide Distribution: AK, AZ, CA, CO, DC, FL, GA, IL, IN, MN, NC, NJ, NY, PA, RI, SC, TX, WI
Why it was recalled
Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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