# FDA recall Z-2229-2019

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2019-07-15.

## Product

Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge  DM FERR    Product Usage:  The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia.

## Reason for recall

Negative Bias with Lot EA9227.

## Distribution

Worldwide Distribution   AK   AR                   AZ                    CA     CT                    FL                    GA                    IA                    ID                    IL                    IN                    KS                    KY                    LA                    MD                    MI                    MN                    MO                    MS                    MT                    NC                    NE                    NH                    NJ                    NY                    OK                    OR                    PR                    SD                    TN                    TX                    VA                    VT                    WA                    WI

## Key facts

- **Recall number:** Z-2229-2019
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-15
- **Report date:** 2019-08-14
- **Termination date:** 2021-08-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2229-2019

## Citation

> AI Analytics. FDA recall Z-2229-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2229-2019. Source: US FDA. Licensed CC0.

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