Reported Jul 8, 2015 · Terminated
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the…
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. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
- Lot codes and dates
- Product
Siemens CentraLink Data Management Systemv14.0.5 Material Number (SMN)10811741108117421081174310814298108148771081488010814881
- Product
CentraLink Data Management Systemv14.0.8 Material Number (SMN)108154741081651910816520108165211081652210816523108165241081718010817181
- Product
- Amount recalled
- 1941
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Siemens Healthcare Diagnostics has determined that the sample query function that includes Instrument or Instrument Group as search criteria may not return all samples from the Dimension Vista systems if onboard aliquot support rules are configured in the CentraLink system.
This product could cause temporary or reversible health problems — stop using it.
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