CLASS II Device recall · Reported 3 Jul 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 in Georgia, Minnesota, New York, Tennessee, Texas. The recall was initiated on 20 Nov 2012 and the FDA has classified it as Class II.
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-1585-2013
- FDA event ID
- 64789
- Recalling firm
- GE Healthcare It, Barrington, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Nov 2012
- FDA classified
- 24 Jun 2013
- Reported
- 3 Jul 2013
- 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 | |
| 24 Jun 2013 | Classified by FDA | +216 days |
| 3 Jul 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different values, in Microbiology result entry when released results (Final Report released) are changed and the Corrected Result messages are edited on the free-text form, some of the originally entered panel free-text is lost. For this issue to occur the original result must be amended and the environmental variabl
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.
Where it was distributed
Worldwide Distribution - US Distribution including the states of OH, NY, GA, TX, TN and MN and the countries of Australia, Qatar and England
Questions about this recall
Why was it recalled?
If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different values, in Microbiology result entry when released results (Final Report released) are changed and the Corrected Result messages are edited on the free-text form, some of the originally entered panel free-text is lost. For this issue to occur the original result must be amended and the environmental variabl
Which lots are affected?
Software Versions 3.3, 4.0, and 4.1
Where was it sold?
Worldwide Distribution - US Distribution including the states of OH, NY, GA, TX, TN and MN and the countries of Australia, Qatar and 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 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Centricity Enterprise Archive recalled by Ge Healthcare It | Ge Healthcare It | Device Malfunction | Nationwide |
| Device | CLASS II | Centricity Laboratory Core Lab System 4.1 The Centricity recalled | GE Healthcare It | Device Malfunction | 6 states |
| Device | CLASS II | GE Centricity PACS Workstation recalled by GE Healthcare It | GE Healthcare It | Other | Nationwide |
| Device | CLASS II | Imagecast Pacs with Centricity Ris-ic versions prior recalled | Ge Healthcare It | Device Malfunction | Nationwide |
| Device | CLASS II | Centricity Enterprise Archive recalled by Ge Healthcare It | Ge Healthcare It | Device Malfunction | Nationwide |
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