FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc: 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
- Recall number
- Z-2228-2012
- 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
- Status
- Terminated
- Initiated
- 2012-07-17
- Posted
- 2012-08-20
- Terminated
- 2013-11-22
- Reason
- Syphilis Assay Interference with HBsAg Assay
- 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
- 2050 Kits
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Foreign: Brazil, China, Denmark, Hong Kong, Malaysia, and New Zealand Viet Nam
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K112343"]
- PMA numbers
- not on file
- Product code
- LIP
- Firm FEI
- 1219913
- Firm city
- East Walpole
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28