Recall Z-2228-2012 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Siemens Healthcare Diagnostics, Inc
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 diagn
| Date | Aug 20, 2012 (initiated Jul 17, 2012) |
| Status | Terminated |
| Reason | Syphilis Assay Interference with HBsAg Assay |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 2050 Kits |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Foreign: Brazil, China, Denmark, Hong Kong, Malaysia, and New Zealand Viet Nam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112343 | TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS Siemens Healthcare Diagnostics, Inc., Jan 20, 2012 |