FDAClass IINovember 27, 2013

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 has become aware of a potential safety issue associated with the use of GE Centricity Laboratory where panel reflex does not occur if DIP.Specimen is blank. Panel reflexing fails to occur when ad-hoc re-routing functionality is used and the following are true: 1) The ordered panel is a slave panel, and; 2) The panitem specimen group field of one or more of the ordered items on the ma

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 - USA (nationwide) including GA and Internationally to Canada and the United Kingdom.
Recall date
November 27, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls