# FDA recall Z-1336-2022

> **Chromsystems Instruments & Chemicals GmbH** · Class II · device recall initiated 2022-05-19.

## Product

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

## Reason for recall

Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.

## Distribution

US:  NY, OH, CT.

## Key facts

- **Recall number:** Z-1336-2022
- **Recalling firm:** Chromsystems Instruments & Chemicals GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-05-19
- **Report date:** 2022-07-13
- **Termination date:** 2024-05-15

- **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-1336-2022

## Citation

> AI Analytics. FDA recall Z-1336-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1336-2022. Source: US FDA. Licensed CC0.

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