Lower riskMedical device recall · FDA · Published December 22, 2022
Siemens Healthcare Diagnostics Recall: Anti-HBe2 Assay Interference with Hepatitis B Tests
Siemens Healthcare recalls ADVIA Centaur XP and XPT Anti-HBe2 assays due to potential false positive Hepatitis B e Antigen results. Affected lots may cause inaccurate test outcomes.
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
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Contact the company
📍Recalling firmSiemens Healthcare Diagnostics, Inc.333 Coney St · East Walpole, MA 02032-1516
“Siemens Healthcare Diagnostics Recall: Anti-HBe2 Assay Interference with Hepatitis B Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59061-siemens-healthcare-diagnostics-recall-anti-hbe2-assay-interference-with-hepatitis. Based on FDA recall #Z-1143-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1143-2023%22&limit=1).
The FDA announced on Dec. 22, 2022, that Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- in vitro diagnostic immunoassays due to a Class II hazard. The device may cause elevated or reactive Hepatitis B e Antigen results in non-reactive samples. This voluntary recall affects 158 units distributed nationwide in Georgia and Utah.
How to tell if you have it
Brand: Siemens Healthcare
Product: ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T-
UPC: 00630414167923
Lot Numbers: B34847, B34848, B35113
Distribution: US Nationwide in GA and UT
The hazard
According to the FDA, Anti-HBe2 interference with the Hepatitis B e Antigen Assay leads to elevated or reactive Hepatitis B e Antigen results on samples that are non-reactive when HBeAg testing follows aHBe2 testing. This occurs regardless of whether both tests are performed on the same sample.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Other recent recalls include the Siemens Atellica CH RCRP Test (Aug. 17, 2026), the Siemens Healthcare Syva EMIT 2000 Quinidine Assay (July 13, 2026), and the Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include the Siemens Healthineers Immulite 2000 Syphilis Screen Recall (July 13, 2026), the TECHNO-PATH Multichem ID-B Serum Recall (Oct. 17, 2025), and the Diagnostica Stago Asserachrom HPIA Kit Recall (Dec. 15, 2025).
How to tell if you have this one
Check the Siemens Material Number (SMN) on the kit: 10720831. Look for lot numbers B34847, B34848, or B35113. The recall affects all current and future lots of these kits until a solution is implemented.
Brand
Siemens Healthcare
Product
ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for lot numbers B34847, B34848, or B35113 on the kit packaging.
Contact Healthcare Provider
Inform your healthcare provider about the recalled kit if you used it recently for hepatitis B testing.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of GA, UT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Georgia, Utah.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1143-2023 (December 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1143-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.