# FDA recall Z-0909-2018

> **Roche Diagnostics Corporation** · Class II · device recall initiated 2017-07-18.

## Product

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001   cobas c 501 module; 2. 05036453001   cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001   cobas 6000 c 501 (UL) V

## Reason for recall

A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during maintenance.

## Distribution

Distributed in all 50 states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MN, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, and Puerto Rico.

## Key facts

- **Recall number:** Z-0909-2018
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-18
- **Report date:** 2018-03-14
- **Termination date:** 2018-07-13

- **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-0909-2018

## Citation

> AI Analytics. FDA recall Z-0909-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0909-2018. Source: US FDA. Licensed CC0.

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