Medical device recalls Moderate risk

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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