# FDA recall Z-1143-2023

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2022-12-22.

## Product

ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (2-21 years old) and adult serum, EDTA plasma, or lithium heparin.  Siemens Material Number (SMN): 10720831

## Reason for recall

Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg testing follows aHBe2 testing, regardless of whether both tests are performed on the same sample

## Distribution

US Nationwide distribution in the states of GA, UT.

## Key facts

- **Recall number:** Z-1143-2023
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-22
- **Report date:** 2023-03-01

- **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-1143-2023

## Citation

> AI Analytics. FDA recall Z-1143-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1143-2023. Source: US FDA. Licensed CC0.

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