Reported Oct 19, 2016 · Terminated
ADVIA Centaur XPT Immunoassay System
Siemens Healthcare Diagnostics, Inc.
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, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- ADVIA Centaur XPT Immunoassay System
- Lot codes and dates
- None
- Amount recalled
- 292 units Total (3 domestically & 289 internationally)
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
Why it was recalled
The ADVIA Centaur¿ XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. Systems running in a language other than English are not impacted.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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