Skip to content
Recall Observatory FDA recall evidence

Device product

Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network.

Z-2671-2016

November 20, 2012

Class II

Product summary

Firm
GE Healthcare It
Event
Event 64796
Status
Terminated
Classification
Class II
Quantity
17
Official record key
device-enforcement:Z-2671-2016

Official wording

Reason: The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the corresponding test (item) results on the master panel. Additionally, the displayed and HL7 results show neither the appropriate abnormal flag value nor the reference range values, when using large_num.g >7 to report numeric results.

Code information: Versions 4.1, 4.0, 3.3.2 & 3.3Almp

Distribution pattern: Worldwide Distribution - US Distribution to GA, OH, NY, TX, TN ,MN and Internationally to India, Australia, Canada, England, Qatar, and Scotland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the corresponding test (item) results on the master panel. Additionally, the displayed and HL7 results show neither the appropriate abnormal flag value nor the reference range values, when using large_num.g >7 to report numeric results.