# FDA recall Z-0754-2021

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2020-12-08.

## Product

Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use  Part Number: 08763662001

## Reason for recall

Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0754-2021
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-12-08
- **Report date:** 2021-01-06

- **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-0754-2021

## Citation

> AI Analytics. FDA recall Z-0754-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0754-2021. Source: US FDA. Licensed CC0.

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