Reported Sep 24, 2014 · Terminated
ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524,…
Siemens Healthcare Diagnostics
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 · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011, 10361012 --- For in vitro diagnostic use This immunoassay system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
- Lot codes and dates
- All Serial Numbers
- Amount recalled
- 10,515 (Domestic: 2771; Foreign: 7744) in total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide.
This product could cause temporary or reversible health problems — stop using it.
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