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 | Eight (8) issues were identified which may affect the results generated by the system software version. |
| Product | ADVIA® Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. |
| Quantity | 446 units Total (3 domestically & 443 internationally) |
| Distribution | Worldwide Distribution - US Nationwide in the states of MD, MN, MS and the countries of Australia, Austria, Bangladesh, Belgium, Canada, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Guadeloupe, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Latvia, Malaysia, Netherlands, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Republic Korea, S… |
| Initiated | 2016-05-26 |
| Classified | 2016-07-21 |
| Terminated | 2018-06-07 |
| Recall number | Z-2256-2016 |
| 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-2256-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74309/
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