# FDA recall Z-1270-2018

> **Roche Diagnostics Corporation** · Class II · device recall initiated 2017-12-18.

## Product

cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for  Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).

## Reason for recall

Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-1270-2018
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-18
- **Report date:** 2018-04-04
- **Termination date:** 2019-04-09

- **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-1270-2018

## Citation

> AI Analytics. FDA recall Z-1270-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1270-2018. Source: US FDA. Licensed CC0.

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