# FDA recall Z-2136-2018

> **Roche Diagnostics Corporation** · Class II · device recall initiated 2018-04-03.

## Product

cobas e 801 immunoassay analyzer, cobas 8000 Modular Series    The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.

## Reason for recall

The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.

## Distribution

US Distribution to the states of :  CA, CT, IA, IN, KY, ME, MI, NC, NY, OH, SC, TX, and VA.

## Key facts

- **Recall number:** Z-2136-2018
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-03
- **Report date:** 2018-06-20
- **Termination date:** 2019-11-21

- **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-2136-2018

## Citation

> AI Analytics. FDA recall Z-2136-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2136-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*