Siemens ADVIA Centaur Syphilis (SYPH) Assay , 200 ReadyPack recallZ-2228-2012 · Siemens Healthcare Diagnostics, Inc · initiated Jul 17, 2012
Class II Terminated All recalls posted in August 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Syphilis Assay Interference with HBsAg Assay
FDA root cause category: Component design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-2228-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 17, 2012
- Posted by the FDA
- Aug 20, 2012
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 2050 Kits
- Product code
- LIP
- FDA submissions
- K112343
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Foreign: Brazil, China, Denmark, Hong Kong, Malaysia, and New Zealand Viet Nam
Product description
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
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
3 devices cleared under K112343 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ADVIA Centaur® SYPH 10492493Siemens Healthcare Diagnostics Inc. · ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM3 reports
- Atellica IM Syph 10995675Siemens Healthcare Diagnostics Inc. · ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM3 reports
- Atellica IM Syph QC 10995676Siemens Healthcare Diagnostics Inc. · ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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