The Recall Desk
HighFDA (Devices)·Z-2671-2016·Announced 2016-09-07

GE Healthcare Recalls Centricity Laboratory Software Due to Data Deletion Errors

GE Healthcare is recalling Centricity Laboratory software versions 3.3 to 4.1 because deleting a slave panel incorrectly removes free-text notes and reference ranges from the master panel.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device software defect that results in the loss of clinical data and missing reference ranges, which poses a risk of harm to patient care, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

GE Healthcare is recalling 17 units of the Centricity Laboratory Core Lab System software, including versions 4.1, 4.0, 3.3.2, and 3.3Almp. The software is an information system designed to support clinical and administrative activities associated with clinical laboratory services, such as storing and delivering analytical results.

The recall is due to a software defect where deleting a slave panel automatically deletes the corresponding test results and free-text notes on the master panel. Additionally, when using the large_num.g >7 setting to report numeric results, the system fails to display appropriate abnormal flag values or reference range values in both the interface and HL7 results.

The affected software was distributed worldwide, including in the United States (GA, OH, NY, TX, TN, MN) and internationally to India, Australia, Canada, England, Qatar, and Scotland. Users of the affected software should contact GE Healthcare for instructions on how to resolve the data integrity issues.

The recalled product

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.,
Manufacturer
GE Healthcare It
Category
Medical Device — Laboratory Information System
Hazard
Affected units
17

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Versions 4.1
  • 4.0
  • 3.3.2 & 3.3Almp

Distribution

Distributed in 6 states:

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