FDAClass IIJuly 3, 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?

If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different values, in Microbiology result entry when released results (Final Report released) are changed and the Corrected Result messages are edited on the free-text form, some of the originally entered panel free-text is lost. For this issue to occur the original result must be amended and the environmental variabl

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, and 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
9 Units
Distribution
Worldwide Distribution - US Distribution including the states of OH, NY, GA, TX, TN and MN and the countries of Australia, Qatar and England
Recall date
July 3, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls