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 | PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU). |
| Product | ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems. |
| Quantity | 55,754 kits |
| Distribution | Worldwide - US Nationwide including Puerto Rico, OUS: Albania, Algeria, Angola, Armenia, Austria, Bahrain, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iceland, Iraq, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Oman, Paki… |
| Initiated | 2015-12-29 |
| Classified | 2016-02-04 |
| Terminated | 2019-11-29 |
| Recall number | Z-0754-2016 |
| 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-0754-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72968/
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