# FDA recall Z-0675-2018

> **Roche Diagnostics Corporation** · Class II · device recall initiated 2017-07-28.

## Product

Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

## Reason for recall

A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.

## Distribution

Distributed in 36 states: AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI and Puerto Rico.

## Key facts

- **Recall number:** Z-0675-2018
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-28
- **Report date:** 2018-02-28
- **Termination date:** 2020-06-10

- **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-0675-2018

## Citation

> AI Analytics. FDA recall Z-0675-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0675-2018. Source: US FDA. Licensed CC0.

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