Centricity Laboratory Core Lab System 4 — Class II medical device recall Z-2671-2016
Terminated recall by GE Healthcare It, reported 2016-09-07, distributed in GA, MN, NY, OH, TN, TX. The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The
| Recall number | Z-2671-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare It, Barrington, IL, United States |
| Recall initiated | 2012-11-20 |
| Classified | 2016-08-26 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2017-12-29 |
| Distributed | GA, MN, NY, OH, TN, TX |
| Countries outside the US | AU, CA, GB, IN, QA |
| Quantity | 17 |
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 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.
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-2671-2016. 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.