Z-0103-2015Class II

ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens...

Name: Z-0103-2015 ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2014-09-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-09-15 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total... on 2014-09-15. FDA classified it as Class II and gives the reason as "Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0103-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-15
Posted: 2014-10-21
Terminated: 2015-12-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.
Product code: LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Reason for recall: Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
FDA root cause: Unknown/Undetermined by firm
Action: Siemens Healthcare issued An Urgent Medical Device Recall (UMDR) sent to all affected Siemens Healthcare Diagnostics customers in the United States on September 15, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 15, 2014. These notices inform the customer of the imprecision and positive bias and a potential increase in initial reactive results associated with ADVIA Centaur Systems HBc Total Lot 100064. Customers were instructed to discontinue use of the affected lots and dispose of the product according to local regulations or procedures. The notices should be reviewed with the facility's laboratory or medical director. Each customer will be required to return a completed confirmation fax-back to Siemens.
Quantity in commerce: 5434
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Austria Bahrain Belgium Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iraq Ireland Italy Jordan Latvia Lebanon Lithuania Luxembourg Netherlands Norway Poland Portugal Romania Slovakia Spain Sweden Switzerland Turkey Unit.Arab Emir and Yemen.
Product codes and lots: Lot Number: 36217064, 36281064, 36449064, 37406064, 38177064 Exp.Date:February 10, 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0103-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0102-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-21
Z-0103-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-21

Product code LOM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)