FDA recall Z-1008-2022

Roche Diabetes Care, Inc. · Class II · 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.

Reason for recall

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2022-03-09
Report date: 2022-05-04
Termination date: 2025-01-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2022