ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2)… recallZ-1143-2023 · Siemens Healthcare Diagnostics, Inc. · initiated Dec 22, 2022

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

Siemens Health issued an Urgent Medical Device Correction (UMDC CC 23-02.A.US) to US customers on 12/22/2022 . The UMDC provides instructions to customers to run the aHBe2 and HBeAg assays on separate systems if possible or to run all aHBe2 tests together and perform the Daily Cleaning Procedure before the HBeAg assay to mitigate the interference. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director. If you have multiple ADVIA Centaur XP or ADVIA Centaur XPT systems in your laboratory, Siemens recommends testing the ADVIA Centaur aHBe2 and ADVIA Centaur HBeAg assays on separate systems to avoid potential interference. If you are testing the ADVIA Centaur HBeAg and ADVIA Centaur aHBe2 assays on the same ADVIA Centaur XP or ADVIA Centaur XPT system, test all aHBe2 samples together followed by the Daily Cleaning Procedure (DCP) prior to testing the HBeAg assay to mitigate the interference. Perform HBeAg Quality Control testing prior to HBeAg patient sample testing. Questions, contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

Recall details

Recall number: Z-1143-2023
Status: Open, Classified
Initiated by the company: Dec 22, 2022
Posted by the FDA: Feb 17, 2023
Recalling firm: Siemens Healthcare Diagnostics, Inc.
Quantity: 158 units
Product code: LOM
Distribution: US Nationwide distribution in the states of GA, UT.

Product description

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

Code information (models, lots, serial numbers)

UDI: (01)00630414167923(10)B34847(17)20230309 (01)00630414167923(10)B34848(17)20230309 (01)00630414167923(10)B35113(17)20230629. Lot Numbers: B34847, B34848, B35113. Affects all current and future lots of the ADVIA Centaur XP and ADVIA Centaur XPT HBeAg assay until a solution is Implemented.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

ADVIA Centaur aHBe2 50T Kit 10720831
Siemens Healthcare Diagnostics Inc. · Qualitative and Quantitative Hepatitis B Virus Antibody assays
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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