Z-2228-2012Class II

Siemens ADVIA Centaur Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493

Name: Z-2228-2012 Siemens ADVIA Centaur Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2012-07-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-07-17 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Siemens ADVIA Centaur Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro... on 2012-07-17. FDA classified it as Class II and gives the reason as "Syphilis Assay Interference with HBsAg Assay". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2228-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-17
Posted: 2012-08-20
Terminated: 2013-11-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens ADVIA Centaur Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasma (EDTA, lithium or sodium heparinized, citrate) using the ADVIA Centaur and ADVIA Centaur XP systems as an aid in the diagnosis of syphilis
Product code: LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Reason for recall: Syphilis Assay Interference with HBsAg Assay
Root cause tag: design
FDA root cause: Component design/selection
Action: Siemens Healthcare sent Urgent Device Recall Notice letters dated July 2012 via e-mail to all affected customers inside and outside the US. The letters identifed the affected product, reason for voluntary recall and risk to health. The letters provided actions to be taken by the customers and if there are any remaining inventory of the affected product, follow the guidelines outlined. Customers were instructed to complete and return the Field Correction Effectiveness Check form. For questions contact your local Technical Support Provider or Distributor.
Quantity in commerce: 2050 Kits
Distribution: Worldwide Distribution - US Nationwide and the countries of: Foreign: Brazil, China, Denmark, Hong Kong, Malaysia, and New Zealand Viet Nam
Product codes and lots: US Lot Number/Exp. Date 85456003 2012-10-13; 86036003 2012-10-13; 87129003 2012-10-13; 88440003 2012-10-13; 90054004 2013-04-09; 90422004 2013-04-09. Outside the US: Kit lots, 77749002, 80615003, 82640003, 84120003, 85456003, 86036003, 87129003,88440003,90054004,90422004.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2228-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2228-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-20

Product code LIP

K112343Class IITreponema Pallidum Treponemal Test Reagents; Quality Control MaterialsSiemens Healthcare Diagnostics, Inc. / cleared 2012-01-20

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)