# FDA recall Z-1504-2023

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2023-03-16.

## Product

Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.

## Reason for recall

There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

## Distribution

Worldwide distribution - US Nationwide.

## Key facts

- **Recall number:** Z-1504-2023
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-16
- **Report date:** 2023-05-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1504-2023

## Citation

> AI Analytics. FDA recall Z-1504-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1504-2023. Source: US FDA. Licensed CC0.

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