Siemens CentraLink" Data Management System V14 — Class II medical device recall Z-0823-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-01-29, distributed in MN, NJ, NV. Under extremely rare circumstances, a patient result that had been previously disabled may be released without
| Recall number | Z-0823-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2013-10-30 |
| Classified | 2014-01-23 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2014-12-15 |
| Distributed | MN, NJ, NV |
| Quantity | 40 |
| Model numbers | 10810210, 10811596, 10814296, 10814298, 10814877, 10815474 |
Product
Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
Reason for recall
Under extremely rare circumstances, a patient result that had been previously disabled may be released without proper review. (Disabled Test in CentraLink System or Aptio System May Become Enabled in CentraLink System.)
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-0823-2014. 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.