Reported Mar 1, 2023 · Ongoing
ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 333 Coney St · East Walpole, MA · 02032-1516
Is this the product you have?
- 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
- Lot codes and dates
- UDI(01)00630414167923(10)B34847(17)20230309 (01)00630414167923(10)B34848(17)20230309 (01)00630414167923(10)B35113(17)20230629
- Lot NumbersB34847, B34848, B35113. Affects all current and future lots of the ADVIA Centaur XP and ADVIA Centaur XPT HBeAg assay until a solution is Implemented
- Amount recalled
- 158 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
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
This product could cause temporary or reversible health problems — stop using it.
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