—#111237

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

FDA product code: LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K112343
Affected lot / code info: 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.

Why it was recalled

Syphilis Assay Interference with HBsAg Assay

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

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

Timeline

Recall initiated: 2012-07-17
Posted by FDA: 2012-08-20
Terminated: 2013-11-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111237. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.