—#198148

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

FDA product code: LOM — Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Device class: Class 2
Medical specialty: Microbiology
Affected lot / 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.

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 Centaur aHBe2 and ADVIA Centaur HBeAg assays on separate systems to avoid potential interference. If you are testing the ADVIA Centaur HBeAg and ADVIA Centaur aHBe2 assays on the same ADVIA Centaur XP or ADVIA Centaur XPT system, test all aHBe2 samples together followed by the Daily Cleaning Procedure (DCP) prior to testing the HBeAg assay to mitigate the interference. Perform HBeAg Quality Control testing prior to HBeAg patient sample testing. Questions, contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: US Nationwide distribution in the states of GA, UT.

Timeline

Recall initiated: 2022-12-22
Posted by FDA: 2023-02-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198148. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.