Z-1008-2022Class II

RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application...

Name: Z-1008-2022 RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application...
Creator: Roche Diabetes Care, Inc.
Published: 2022-03-09
License: https://open.fda.gov/license/

Roche Diabetes Care, Inc. / initiated 2022-03-09 / Terminated / root cause: software

FDA source

Roche Diabetes Care, Inc. began a recall of 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... on 2022-03-09. FDA classified it as Class II and gives the reason as "Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1008-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-09
Posted: 2022-04-26
Terminated: 2025-01-22
Recalling firm: Roche Diabetes Care, Inc.
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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.
Root cause tag: software
FDA root cause: Software design
Action: Urgent Medical Device Correction Notice 22-001 was issued March 09, 2022 via email. The software issue was resolved with the cloud-based software update to version 2.5.5 on February 24, 2022. No further action required. Customers to submit notification acknowledgement. Contact your Roche Account Manager or contact Accu-Chek Customer Care at 1-800-628-3346 with questions.
Quantity in commerce: 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
Product codes and lots: Date of manufacture: 2021-11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1008-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1008-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-04	2022-04-26

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)