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 2012-10-13
    • 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
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 22, 2013 · Data as of Sep 19, 5:25 PM UTC

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