RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hoste
Summary
The FDA issued a Class II for RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. by Roche Diabetes Care, Inc.. Reason: Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software..
Details
Source
Device Recall
External ID
Z-1008-2022
Action Date
2022-05-04
Status
Terminated
Category
device
Product Description
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.
Lot/Code Info: Date of manufacture: 2021-11
Quantity Affected: 81 registered accounts
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-09
Company
Indianapolis, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Roche Diabetes Care, Inc. has 13 FDA actions in our database, including 6 recalls and 7 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Roche Diabetes Care, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Roche Diabetes Care, Inc. have FDA actions?
Roche Diabetes Care, Inc. has 13 FDA actions in our database, including 6 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1008-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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