ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 — Class II medical device recall Z-1143-2023
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2023-03-01, distributed nationwide. Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hep
| Recall number | Z-1143-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., East Walpole, MA, United States |
| Recall initiated | 2022-12-22 |
| Classified | 2023-02-17 |
| Reported by FDA | 2023-03-01 |
| Distributed | Nationwide (US) |
| Quantity | 158 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414167923 |
| Lot numbers | B34847, B34848, B35113 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1143-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.