# FDA recall Z-0679-2020

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2019-10-04.

## Product

Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems   Catalog  Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.

## Reason for recall

Homocysteine Reagent, Calibration Failures and  Quality Control Recovery Issues on cobas c 701 and 702 modules

## Distribution

US Nationwide distribution in the states of NJ, HI, IA.

## Key facts

- **Recall number:** Z-0679-2020
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-04
- **Report date:** 2019-12-25
- **Termination date:** 2020-10-09

- **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-0679-2020

## Citation

> AI Analytics. FDA recall Z-0679-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0679-2020. Source: US FDA. Licensed CC0.

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