CLASS II Device recall · Reported 27 Nov 2013 · FDA Enforcement Report

The Centricity Laboratory System is intended to be recalled

GE Healthcare It is recalling The Centricity Laboratory System is intended to be an information system designed to, distributed nationwide in the US. The recall was initiated on 12 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Versions: 3.3, 4.0, 4.1

Quantity recalled7 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0330-2014
FDA event ID: 64806
Recalling firm: GE Healthcare It, Barrington, IL
Classification: Class II
Status: Terminated
Recall initiated: 12 Mar 2013
FDA classified: 15 Nov 2013
Reported: 27 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

12 Mar 2013	Recall initiated by company
15 Nov 2013	Classified by FDA	+248 days
27 Nov 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users

Where it was distributed

Worldwide Distribution - USA (nationwide) including GA and Internationally to Canada and the United Kingdom.

Nationwide Georgia

Questions about this recall

Why was it recalled?

Which lots are affected?

Software Versions: 3.3, 4.0, 4.1

Where was it sold?

Worldwide Distribution - USA (nationwide) including GA and Internationally to Canada and the United Kingdom.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from GE Healthcare It

All 17

Reported	Class	Recall	Company	Reason	Where
14 Sep 2016Device	CLASS II	Centricity Enterprise Archive recalled by Ge Healthcare It	Ge Healthcare It	Device Malfunction	Nationwide
7 Sep 2016Device	CLASS II	Centricity Laboratory Core Lab System 4.1 The Centricity recalled	GE Healthcare It	Device Malfunction	6 states
24 Aug 2016Device	CLASS II	GE Centricity PACS Workstation recalled by GE Healthcare It	GE Healthcare It	Other	Nationwide
3 Aug 2016Device	CLASS II	Imagecast Pacs with Centricity Ris-ic versions prior recalled	Ge Healthcare It	Device Malfunction	Nationwide
31 Dec 2014Device	CLASS II	Centricity Enterprise Archive recalled by Ge Healthcare It	Ge Healthcare It	Device Malfunction	Nationwide

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