# FDA recall Z-1816-2022

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2022-08-17.

## Product

Dimension Magnesium (MG) Flex reagent cartridge  Siemens  Material Number (SMN)/REF (Catalog Number):10444963/DF57

## Reason for recall

Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be  produced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of -15 to -59% may occur

## Distribution

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## Key facts

- **Recall number:** Z-1816-2022
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-17
- **Report date:** 2022-10-05

- **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-1816-2022

## Citation

> AI Analytics. FDA recall Z-1816-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1816-2022. Source: US FDA. Licensed CC0.

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