CLASS III Device recall · Reported 5 Feb 2014 · 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 20 Nov 2012 and the FDA has classified it as Class III.
Check your package
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-0865-2014
- FDA event ID
- 64795
- Recalling firm
- GE Healthcare It, Barrington, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Nov 2012
- FDA classified
- 29 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Nov 2012 | Recall initiated by company | |
| 29 Jan 2014 | Classified by FDA | +435 days |
| 5 Feb 2014 | Published in enforcement report | +7 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 is aware of a potential safety issue associated with the use of GE Centricity Laboratory Core Lab calculated results in two scenarios. In Scenario 1: Calculated results greater than 6 digits plus a decimal are reported as 0 instead of TOO BIG when significant figures are not defined for the item. In Scenario 2: Calculated results greater than 6 digits plus a decimal are trunc
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 - US (Nationwide) to states of: MN, GA, and CA; and International to: England.
Questions about this recall
Why was it recalled?
GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Laboratory Core Lab calculated results in two scenarios. In Scenario 1: Calculated results greater than 6 digits plus a decimal are reported as 0 instead of TOO BIG when significant figures are not defined for the item. In Scenario 2: Calculated results greater than 6 digits plus a decimal are trunc
Which lots are affected?
Software Versions: 3.3, 4.0, 4.1
Where was it sold?
Worldwide Distribution - US (Nationwide) to states of: MN, GA, and CA; and International to: England.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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