# FDA recall Z-1024-2022

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2022-03-03.

## Product

ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots

## Reason for recall

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

## Distribution

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.

## Key facts

- **Recall number:** Z-1024-2022
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-03
- **Report date:** 2022-05-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Walpole, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1024-2022

## Citation

> AI Analytics. FDA recall Z-1024-2022. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-1024-2022. Source: US FDA. Licensed CC0.

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