Reported Sep 7, 2016 · Terminated

Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system…

GE Healthcare It

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare It · 540 W Northwest Hwy · Barrington, IL · 60010-3051

Is this the product you have?

  • 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.
Lot codes and dates
    • Versions 4.1
    • 4.0
    • 3.3.2 & 3.3Almp
Amount recalled
17

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 29, 2017 · Data as of Sep 19, 6:03 PM UTC

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