Z-1143-2023Class II

ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the...

Name: Z-1143-2023 ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2022-12-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-12-22 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2022-12-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1143-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-22
Posted: 2023-02-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
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
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 158 units
Distribution: US Nationwide distribution in the states of GA, UT.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1143-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1143-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-01	2023-02-17

Product code LOM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)