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 | Ongoing |
| Reason | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay. |
| Product | Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000 |
| Quantity | US: 123 OUS: 751 |
| Distribution | Nationwide Foreign: Country Name Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile Colombia Croatia Curaao Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Greece Hungary India Indonesia Iraq Ireland Israel Italy Japan Kenya Kuwait Latvia Libya Lithuania Malaysia Mexico Moro… |
| Initiated | 2021-05-13 |
| Classified | 2021-07-07 |
| Recall number | Z-2028-2021 |
| 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-2028-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88056/
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