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 | Stability of the ADVIA Centaur Cleaning Solution is not assured |
| Product | ADVIA Centaur® and ADVIA Centaur® XP and ADVIA Centaur® CP Cleaning Solution (For in vitro diagnostic use with the ADVIA® Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur® and ADVIA Centaur® XP and ADVIA Centaur® CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments. |
| Quantity | 4645 (12 pk) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada. Grerat Britain, Saudi Arabia, Nepal, and Viet Nam. |
| Initiated | 2014-09-12 |
| Classified | 2014-11-14 |
| Terminated | 2015-07-17 |
| Recall number | Z-0214-2015 |
| 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 III recall — Siemens Healthcare Diagnostics, Inc (Z-0214-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69282/
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