Siemens Healthcare Diagnostics, Inc. Recall 91552
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
Siemens Healthcare Diagnostics, Inc. Recall 91552 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1143-2023 |
| Event ID | 91552 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of GA, UT. |
| Quantity | 158 units |
| Recall Reason | 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 |
| Device Classification | 20230301 |
| Device Code Info | 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. |
| Center Classification Date | 20230217 |
| Recall Initiation Date | 20221222 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
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