Siemens ADVIA Centaur Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur S
FDA device recall Z-2228-2012 · posted 2012-08-20 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Reason for recall
- Syphilis Assay Interference with HBsAg Assay
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- LIP
- Quantity affected
- 2050 Kits
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Foreign: Brazil, China, Denmark, Hong Kong, Malaysia, and New Zealand Viet Nam
- Date initiated
- 2012-07-17
- Date posted
- 2012-08-20
- Date terminated
- 2013-11-22
- Location
- East Walpole, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS (K112343) | Siemens Healthcare Diagnostics, Inc. | 2012-01-20 |