The Centricity Laboratory System is intended to be an recall
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated…
Why was The Centricity Laboratory System is intended to be an recalled?
GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instrument Interface (IF) where free-text sent from IM is not being transcribed into free-text in iNET. The instrument may upload results to IF/iNET when order/request is not yet in IF/iNET. In such a situation, test level supporting free-text sent from the instrument is discarded (not captured).
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?
Software Versions: 3.3, 4.0, 4.1
- Product
- The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated…
- Recalling firm
- GE Healthcare It
- Quantity
- 5 units
- Distribution
- Worldwide Distribution - US including MN and Internationally to India, Australia, Canada, and England.
- Recall date
- January 8, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)