Recall Z-1008-2022 ยท JQP Calculator/Data Processing Module, For Clinical Use
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.
| Date | Mar 9, 2022 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.