The Centricity Laboratory System is intended to be an information… — Class II medical device recall Z-0620-2014
Terminated recall by GE Healthcare It, reported 2014-01-08, distributed in MN. GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instrument Interfa
| Recall number | Z-0620-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare It, Barrington, IL, United States |
| Recall initiated | 2013-03-12 |
| Classified | 2014-01-02 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2016-06-10 |
| Distributed | MN |
| Countries outside the US | AU, CA, GB, IN |
| Quantity | 5 units |
Product
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
Reason for recall
GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instrument Interface (IF) where free-text sent from IM is not being transcribed into free-text in iNET. The instrument may upload results to IF/iNET when order/request is not yet in IF/iNET. In such a situation, test level supporting free-text sent from the instrument is discarded (not captured).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0620-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.