Reported Aug 29, 2012 · Terminated
Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc · 333 Coney St · East Walpole, MA · 02032-1516
Is this the product you have?
- Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack
- Reference Number 10492493 Product UsageThe 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
- Lot codes and dates
US Lot Number/Exp. Date 85456003 2012-10-1386036003 2012-10-1387129003 2012-10-1388440003 2012-10-1390054004 2013-04-0990422004 2013-04-09
- Outside the US
Kit lots77749002806150038264000384120003854560038603600387129003884400039005400490422004
- Amount recalled
- 2050 Kits
Where it was sold
- Nationwide
Why it was recalled
Syphilis Assay Interference with HBsAg Assay
This product could cause temporary or reversible health problems — stop using it.
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