# FDA recall Z-1688-2018

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2018-01-02.

## Product

ADVIA Centaur¿ DHEA-SO4

## Reason for recall

The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere

## Distribution

Nationwide and Canada, Mexico, and Thailand

## Key facts

- **Recall number:** Z-1688-2018
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-02
- **Report date:** 2018-05-16
- **Termination date:** 2023-02-10

- **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-1688-2018

## Citation

> AI Analytics. FDA recall Z-1688-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1688-2018. Source: US FDA. Licensed CC0.

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