Hepatitis B Diagnostic Test Kits Recalled for Test Interference
Siemens is recalling ADVIA Centaur diagnostic test kits used to detect hepatitis B antibodies due to test interference that can produce false positive results when performed before another hepatitis B test on the same sample.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall without reported illnesses or injuries, but the hazard—test interference causing false positive diagnostic results—poses a risk of misdiagnosis and clinical harm. Per the severity rubric, recalls involving risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T diagnostic test kits. These in vitro diagnostic immunoassays are used to detect antibodies to the hepatitis B e antigen in blood samples from pediatric patients aged 2-21 years and adults.
The recall is due to test interference. When the aHBe2 test is performed immediately before the Hepatitis B e Antigen (HBeAg) test on the same sample, the aHBe2 test can interfere with the HBeAg results, causing them to appear elevated or reactive when they should be negative. This interference can lead to misinterpretation of test results.
Approximately 158 units were distributed nationwide, with identified distribution in Georgia and Utah. The recall affects lot numbers B34847, B34848, and B35113, as well as all current and future lots of the ADVIA Centaur HBeAg assay until a solution is implemented.
Healthcare providers and laboratories using affected test kits should contact Siemens Healthcare Diagnostics, Inc. for guidance on proper testing procedures and next steps. Testing protocols that perform aHBe2 before HBeAg on the same sample should be reviewed to prevent false positive HBeAg results.
The recalled product
- 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.…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 158
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- B34848
Distribution
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · test interference
See all →- HighFetal Membrane Rupture Test Kits Recalled for False Positive Results
FDA (Devices) · 2024-04-24
- HighSiemens Atellica Lab Analyzers Risk Falsely Elevated Cholesterol Results
FDA (Devices) · 2024-04-24
- HighAbbott Alinity i Anti-HCV Reagent Kit Recall for Falsely Elevated Test Results
FDA (Devices) · 2024-04-10
- HighFDA Recalls V8 Immunodisplacement Kit Due to Microbial Contamination
FDA (Devices) · 2022-06-15
- HighAbbott Activated Alanine Aminotransferase Reagent Recalled for Inaccurate Test Results
FDA (Devices) · 2021-08-11
Similar recalls
- ModerateSiemens Syphilis Assay Recalled Due to Interference with Hepatitis B Testing
FDA (Devices) · 2012-08-29
- HighSiemens ADVIA Centaur HBc Total Kit Recalled for Increased Imprecision
FDA (Devices) · 2014-10-29
- HighSiemens HSV-2 Test Kits Recalled for Potential False Positive Results
FDA (Devices) · 2021-03-24
- ModerateSiemens ADVIA Centaur HBc IgM Recalled for Biotin Interference
FDA (Devices) · 2018-05-16
- HighSiemens ADVIA Centaur HBc Total Reagent Recalled for Increased Imprecision
FDA (Devices) · 2014-10-29
- HighSiemens ADVIA Centaur Folate Test Kits Recalled for Potential Interference
FDA (Devices) · 2020-01-29