CLASS II Device recall · Reported 7 Sep 2016 · FDA Enforcement Report
Centricity Laboratory Core Lab System 4.1 The Centricity recalled
GE Healthcare It is recalling Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to, distributed in Georgia, Minnesota, New York, Ohio, 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-2671-2016
- FDA event ID
- 64796
- Recalling firm
- GE Healthcare It, Barrington, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Nov 2012
- FDA classified
- 26 Aug 2016
- Reported
- 7 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 20 Nov 2012 | Recall initiated by company | |
| 26 Aug 2016 | Classified by FDA | +1375 days |
| 7 Sep 2016 | 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
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.
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
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.
Where it was distributed
Worldwide Distribution - US Distribution to GA, OH, NY, TX, TN ,MN and Internationally to India, Australia, Canada, England, Qatar, and Scotland.
Questions about this recall
Why was it 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.
Which lots are affected?
Versions 4.1, 4.0, 3.3.2 & 3.3Almp
Where was it sold?
Worldwide Distribution - US Distribution to GA, OH, NY, TX, TN ,MN and Internationally to India, Australia, Canada, England, Qatar, and Scotland.
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
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|---|---|---|---|---|---|
| Device | CLASS II | Centricity Enterprise Archive recalled by Ge Healthcare It | Ge Healthcare It | Device Malfunction | Nationwide |
| 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 |
| Device | CLASS III | The Centricity Laboratory System is intended to be recalled | GE Healthcare It | Device Malfunction | Nationwide |
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