ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for...
FDA Recall #Z-1143-2023 — Class II — December 22, 2022
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
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
Recalling Firm
Siemens Healthcare Diagnostics, Inc. — East Walpole, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
158 units
Distribution
US Nationwide distribution in the states of GA, UT.
Code Information
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated