# FDA recall Z-2476-2019

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2019-07-18.

## Product

cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001

## Reason for recall

Quality issue with high pressure solenoid valves may cause inaccurate results.

## Distribution

State  NY  MT  HI  IN  MD  TX  OH  KS  KY  CA  FL  OR  LA  MO  AK

## Key facts

- **Recall number:** Z-2476-2019
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-18
- **Report date:** 2019-09-11
- **Termination date:** 2020-06-15

- **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-2476-2019

## Citation

> AI Analytics. FDA recall Z-2476-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2476-2019. Source: US FDA. Licensed CC0.

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