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.
FDA Recall Z-1008-2022 · Posted None
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Recalling FirmRoche Diabetes Care, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2022-03-09
Date Terminated2025-01-22
Product Quantity81 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.
Firm 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.
Root Cause
Software design
Distribution Pattern
US Nationwide Distribution: AK, AZ, CA, CO, DC, FL, GA, IL, IN, MN, NC, NJ, NY, PA, RI, SC, TX, WI
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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