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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur XP and ADVIA Centaur XPT AntiHBe2 (aHBe2)

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  Class 2 Device Recall ADVIA Centaur XP and ADVIA Centaur XPT AntiHBe2 (aHBe2) see related information
Date Initiated by Firm December 22, 2022
Date Posted February 17, 2023
Recall Status1 Open3, Classified
Recall Number Z-1143-2023
Recall Event ID 91552
Product Classification Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
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
Code Information 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.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact SAME
508-668-5000
Manufacturer 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
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 158 units
Distribution US Nationwide distribution in the states of GA, UT.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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