FDAClass IIMay 4, 2022

RocheDiabetes Care Platform Software version 2.5.2 recall: Software Issue

RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no…

Why was RocheDiabetes Care Platform Software version 2.5.2 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Date of manufacture: 2021-11

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…
Recalling firm
Roche Diabetes Care, Inc.
Quantity
81 registered accounts
Distribution
US Nationwide Distribution: AK, AZ, CA, CO, DC, FL, GA, IL, IN, MN, NC, NJ, NY, PA, RI, SC, TX, WI
Recall date
May 4, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls