FDA Device recall Z-2671-2016
Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the…
- FDA Device
- Class II
- terminated
- Published 2016-09-07
On 2016-09-07 the FDA classified a Class II recall of Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the… by Ge Healthcare It, citing 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 (….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2671-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-20 |
| Published | 2016-09-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare It |
| Distribution | GA, MN, NY, OH, TN, TX |
Product
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.
Reason
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.
Identifiers
| code_info | Versions 4.1, 4.0, 3.3.2 & 3.3Almp |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2671-2016%22
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