CentraLink¿ Data Management System Software Versions: v13x — Class II medical device recall Z-1204-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2017-02-22, distributed nationwide. There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifyi
| Recall number | Z-1204-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2016-11-29 |
| Classified | 2017-02-15 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2018-06-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 3,893 units |
Product
CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x 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. Siemens Healthcare Diagnostics has determined that there is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type.
Reason for recall
There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. This can occur when an order is received from the LIS without a sample type, requiring that the sample type be set in CentraLink based on the sample type of the test in the order.
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-1204-2017. 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.