# FDA recall Z-0522-2021

> **Chromsystems Instruments & Chemicals GmbH** · Class II · device recall initiated 2020-10-29.

## Product

MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

## Reason for recall

Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

## Distribution

US Nationwide distribution in the states of NC and NY.

## Key facts

- **Recall number:** Z-0522-2021
- **Recalling firm:** Chromsystems Instruments & Chemicals GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2020-10-29
- **Report date:** 2020-12-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grafelfing, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0522-2021

## Citation

> AI Analytics. FDA recall Z-0522-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0522-2021. Source: US FDA. Licensed CC0.

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