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 | Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves. |
| Product | Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref) |
| Quantity | Total = 19,352 (13,881 - 2 pack, 4878 - 6 pack, 593 - 6 pack REF) |
| Distribution | Nationwide including Puerto Rico. Worldwide: Afghanistan, Armenia, Austria, Bahrain, Belgium, Bulgaria, Burkina Faso, Canary Islands, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iran, Iraq, Ireland, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Oman… |
| Initiated | 2014-09-26 |
| Classified | 2014-10-31 |
| Terminated | 2016-01-29 |
| Recall number | Z-0164-2015 |
| 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 II recall — Siemens Healthcare Diagnostics, Inc (Z-0164-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69430/
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