Recall Z-1143-2023 ยท LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Siemens Healthcare Diagnostics, Inc.
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
| Date | Feb 17, 2023 (initiated Dec 22, 2022) |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Siemens Health issued an Urgent Medical Device Correction (UMDC CC 23-02.A.US) to US customers on 12/22/2022 . The UMDC provides instructions to customers to run the aHBe2 and HBeAg assays on separate systems if possible or to run all aHBe2 tests together and perform the Daily Cleaning Procedure before the HBeAg assay to mitigate the interference. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director. If you have multiple ADVIA Centaur XP or ADVIA Centaur XPT systems in your laboratory, Siemens recommends testing the ADVIA Centau |
| Quantity | 158 units |
| Distribution | US Nationwide distribution in the states of GA, UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.