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Recall Observatory FDA recall evidence

Device 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

Z-2228-2012

July 17, 2012

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 62640
Status
Terminated
Classification
Class II
Quantity
2050 Kits
Official record key
device-enforcement:Z-2228-2012

Official wording

Reason: Syphilis Assay Interference with HBsAg Assay

Code information: 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.

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Foreign: Brazil, China, Denmark, Hong Kong, Malaysia, and New Zealand Viet Nam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Syphilis Assay Interference with HBsAg Assay