Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics has determined that the sample query function that includes Instrument or Instrument Group as search criteria may not return all samples from the Dimension Vista systems if onboard aliquot support rules are configured in the CentraLink system. |
| Product | CentraLink" Data Management 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. |
| Quantity | 1941 |
| Distribution | Worldwide Distribution - Nationwide Distribution and to the countries of : Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland and United Kingdom. |
| Initiated | 2015-05-19 |
| Classified | 2015-07-02 |
| Terminated | 2018-04-27 |
| Recall number | Z-1957-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-1957-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71362/
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