# FDA recall Z-0499-2018

> **Roche Diagnostics Corporation** · Class II · device recall initiated 2017-07-05.

## Product

Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244  - Elecsys 2010    Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.

## Reason for recall

A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.

## Distribution

Nationwide Distribution

## Key facts

- **Recall number:** Z-0499-2018
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-05
- **Report date:** 2018-02-07
- **Termination date:** 2019-04-30

- **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-0499-2018

## Citation

> AI Analytics. FDA recall Z-0499-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0499-2018. Source: US FDA. Licensed CC0.

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