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 associated with the use of GE Centricity Laboratory Core Lab calculated results in two scenarios. In Scenario 1: Calculated results greater than 6 digits plus a decimal are reported as 0 instead of TOO BIG when significant figures are not defined for the item. In Scenario 2: Calculated results greater than 6 digits plus a decimal are trunc
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
- 7 units
- Distribution
- Worldwide Distribution - US (Nationwide) to states of: MN, GA, and CA; and International to: England.
- Recall date
- February 5, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)