ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detect

FDA device recall Z-1143-2023 · posted 2023-02-17 · Open, Classified

Recall details

Recalling firm

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LOM

Quantity affected

158 units

Distribution

US Nationwide distribution in the states of GA, UT.

Date initiated

2022-12-22

Date posted

2023-02-17

Location

East Walpole, MA