# FDA recall Z-1249-2019

> **Roche Diagnostics Corporation** · Class II · device recall initiated 2019-03-15.

## Product

cobas e 801 immunoassay analyzer

## Reason for recall

The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.

## Distribution

Distributed to accounts in AL  AZ  CA  CT  FL  HI  IA  IL  IN  KY  LA  MA  MD  ME  MI  MN  MO  NC  NH  NJ  NY  OH  OR  PA  PR  SC  TN  TX  VA  WA  WI

## Key facts

- **Recall number:** Z-1249-2019
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-15
- **Report date:** 2019-05-08
- **Termination date:** 2020-04-23

- **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-1249-2019

## Citation

> AI Analytics. FDA recall Z-1249-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1249-2019. Source: US FDA. Licensed CC0.

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