FDAClass IISeptember 10, 2014

Siemens EasyLink Informatics System V4.0/V5 Siemens recall

Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists…

Why was Siemens EasyLink Informatics System V4.0/V5 Siemens recalled?

May not perform as intended under certain conditions, causing the release of results to the Laboratory Information System (LIS) that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

EasyLink Informatics System V4.0/V5 Siemens Material Number (SMN) 10444799, 10444800, 10487219

Product
Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists…
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
1347
Distribution
US Nationwide Distribution
Recall date
September 10, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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