Siemens Healthcare recalls ADVIA Centaur XP and XPT Anti-HBe2 assays due to potential false positive Hepatitis B e Antigen results. Affected lots may cause inaccurate test outcomes.
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
Siemens Healthcare is recalling ADVIA Centaur XP and XPT Anti-HBe2 (aHBe2) 50T diagnostic kits because they can cause false positive Hepatitis B e Antigen results. This means tests might show hepatitis B activity when there is none, leading to incorrect health decisions.
The Anti-HBe2 test can interfere with the Hepatitis B e Antigen (HBeAg) test, causing false positive results. This means a patient might be incorrectly identified as having active hepatitis B when they do not, potentially leading to unnecessary treatment or anxiety.
Healthcare providers using these kits for hepatitis B testing in patients aged 2-21 years and adults. Those who have recently used the affected kits may get inaccurate results.
Check the Siemens Material Number (SMN) on the kit: 10720831. Look for lot numbers B34847, B34848, or B35113. The recall affects all current and future lots of these kits until a solution is implemented.
Look for lot numbers B34847, B34848, or B35113 on the kit packaging.
Inform your healthcare provider about the recalled kit if you used it recently for hepatitis B testing.
The Anti-HBe2 (aHBe2) test can cause false positive results in Hepatitis B e Antigen (HBeAg) tests, meaning patients might be incorrectly identified as having active hepatitis B.
All ADVIA Centaur XP and XPT Anti-HBe2 (aHBe2) 50T kits with lot numbers B34847, B34848, or B35113.
No, but you should check your kit's lot number and contact your healthcare provider if you used the affected kits recently.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1143-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1143-2023 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
