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
Reported: August 29, 2012 Initiated: July 17, 2012 #Z-2228-2012
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
Reason for Recall
Syphilis Assay Interference with HBsAg Assay
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 2050 Kits
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Foreign: Brazil, China, Denmark, Hong Kong, Malaysia, and New Zealand Viet Nam
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 2050 Kits.
Why was this product recalled? ▼
Syphilis Assay Interference with HBsAg Assay
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2012. Severity: Moderate. Recall number: Z-2228-2012.
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