FDA Medical Device Recalls (openFDA)
Roche Diabetes Care, Inc.: 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.
- Recall number
- Z-1008-2022
- 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.
- Status
- Terminated
- Initiated
- 2022-03-09
- Posted
- not on file
- Terminated
- 2025-01-22
- Reason
- Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.
- 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
- 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
- Lot, serial or model codes
- Date of manufacture: 2021-11
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 3011393376
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28