Reported Feb 22, 2017 · Terminated
CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network…
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?
- CentraLink¿ Data
- Management System Software Versionsv13x,v14x,v15x The CentraLink 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. Siemens Healthcare Diagnostics has determined that there is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type
- Lot codes and dates
- Product codes
104850611048421210485064104834391047139310484552108142961081547411220480104819361048193710481938104821701048293610483437104834381048344010484211104842131048506010485062104850631070300710703008107116381071163910711640107116411071164310811596108115971081159810811599108116011081174110811742108117431081429810814877108148801081488110815694108165191081652010816521108165221081652310816524108171801081718110819760108199431121984011219841
- Product codes
- Amount recalled
- 3,893 units
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
There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. This can occur when an order is received from the LIS without a sample type, requiring that the sample type be set in CentraLink based on the sample type of the test in the order.
This product could cause temporary or reversible health problems — stop using it.
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