EasyLink Informatic System is included with the recall
EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device…
Why was EasyLink Informatic System is included with the recalled?
When using the EasyLink Quality Control Package the system may not perform as intended for Multi-Rule QC violations [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions send with the Urgent Field Safety Notice. When this situation occurs, QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient
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?
Part Number: 1000034805, Version 5.0 and Version 5.0 Service Pack 1 through 4
- Product
- EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 637
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, France, Germany, Spain, Portugal, Italy, Japan, Norway, Australia, Austria, New Zealand, Belgium, Switzerland, Netherlands, Malaysia, Slovenia, South Korea, Denmark, Saudi Arabia, Slovakia, Taiwan, Philippines, Czech Republic, and Singapore.
- Recall date
- August 29, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)