The Recall Desk
HighFDA (Devices)·Z-1143-2023·Announced 2023-03-01

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.

What this means for you

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. Siemens
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
  • test-interference
  • false-positive

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

Distributed nationwide across the United States.

Related recalls

Same category