# FDA recall Z-1008-2022

> **Roche Diabetes Care, Inc.** · Class II · device recall initiated 2022-03-09.

## 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.

## Reason for recall

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

## Distribution

US Nationwide Distribution: AK, AZ, CA, CO, DC, FL, GA, IL, IN, MN, NC, NJ, NY, PA, RI, SC, TX, WI

## Key facts

- **Recall number:** Z-1008-2022
- **Recalling firm:** Roche Diabetes Care, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-03-09
- **Report date:** 2022-05-04
- **Termination date:** 2025-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2022

## Citation

> AI Analytics. FDA recall Z-1008-2022. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1008-2022. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*