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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Siemens Healthcare Diagnostics, Inc.
- Reason for Recall:
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1143-2023
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