The Centricity Laboratory System is intended to be an information… — Class II medical device recall Z-1585-2013
Terminated recall by GE Healthcare It, reported 2013-07-03, distributed in GA, MN, NY, OH, TN, TX. If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different values, in Microbiol
| Recall number | Z-1585-2013 |
|---|---|
| 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 | 2013-06-24 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2016-06-10 |
| Distributed | GA, MN, NY, OH, TN, TX |
| Countries outside the US | AU, GB, QA |
| Quantity | 9 units |
| Reason classes | microbial contamination |
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.
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
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-1585-2013. 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.