Class III — 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 III |
| Status | Terminated |
| Reason | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h |
| Product | Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids. |
| Quantity | 2207 total |
| Distribution | Worldwide Distribution. |
| Initiated | 2013-02-27 |
| Classified | 2013-04-01 |
| Terminated | 2014-01-14 |
| Recall number | Z-1048-2013 |
| 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 III recall — Siemens Healthcare Diagnostics, Inc. (Z-1048-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64570/
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