# FDA recall Z-0378-2018

> **Roche Diagnostics Corporation** · Class II · device recall initiated 2017-06-29.

## Product

Brand Name:  ¿ cobas c 6000 MODULAR Series System   e 601  ¿ cobas c 8000 MODULAR Series System - e 602  ¿ Roche / Hitachi MODULAR Analytics Combination System    Model/Catalog/Part Number:  MODULAR Analytics E 170  ¿ 03022109001  ¿ 03023109973  ¿ 03739040001  ¿ 03739040692  ¿ 05023572001  ¿ 05023599001  cobas e 601 module  ¿ 04745922001  ¿ 04745922692  ¿ 05036348001  ¿ 05036348692  ¿ 05860652001  cobas e 602 module  ¿ 05990378001      The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environme

## Reason for recall

Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation.

## Distribution

USA (nationwide) Distribution

## Key facts

- **Recall number:** Z-0378-2018
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-29
- **Report date:** 2018-01-24
- **Termination date:** 2020-01-24

- **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-0378-2018

## Citation

> AI Analytics. FDA recall Z-0378-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0378-2018. Source: US FDA. Licensed CC0.

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