# FDA recall Z-2054-2018

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2017-12-18.

## Product

ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)

## Reason for recall

In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays.

## Distribution

Distributed in the following U.S. states: AL, CA, DE, GA, IA, IL, IN, KY, MA, MI, MS, MT, NC, ND, NJ, NM, NV, NY, OH, PA, RI, TN, TX, VA, WA, WV, WY and Puerto Rico. Distributed in the following OUS countries: Australia  Belgium¿¿¿¿¿¿¿¿  Canada  Chile  France¿¿¿¿¿¿¿¿¿  Germany¿¿¿¿¿¿¿¿  Greece¿¿¿¿¿¿¿¿¿  Israel  Italy¿¿¿¿¿¿¿¿¿¿  Japan  Latvia¿¿¿¿¿¿¿¿¿  Luxembourg¿¿¿¿¿  Netherlands¿¿¿¿  New Zealand  Norway¿¿¿¿¿¿¿¿¿  Poland¿¿¿¿¿¿¿¿¿  Portugal¿¿¿¿¿¿¿  Romania¿¿¿¿¿¿¿¿  Singapore  Slovakia¿¿¿¿¿¿¿  South Africa  Spain¿¿¿¿¿¿¿¿¿¿  Switzerland¿¿¿¿  U.A.E.¿¿¿¿¿¿¿¿¿  United¿Kingdom¿

## Key facts

- **Recall number:** Z-2054-2018
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2017-12-18
- **Report date:** 2018-06-13

- **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-2054-2018

## Citation

> AI Analytics. FDA recall Z-2054-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2054-2018. Source: US FDA. Licensed CC0.

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