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 | Incorrect calibrator level listed in qualitative calibration steps |
| Product | Syva® EMIT® II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483 |
| Quantity | N/A |
| Distribution | PA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign |
| Initiated | 2018-03-12 |
| Classified | 2018-05-10 |
| Terminated | 2020-06-02 |
| Recall number | Z-1799-2018 |
| 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-1799-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79699/
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