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 | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40 |
| Product | ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use in the quantitative determination of prolactin in serum using the ADVIA Centaur System. ADVIA Centaur Calibrator B: For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur® Systems: Digoxin, FSH, TotallgE, LH, LH2, Prolactin, Total hCG, and TSH |
| Quantity | 15, 455 kits |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Canada, Argentina, Australia, Bangaldesh,Brazil, Chile, China, Columbia, Croatia, Ecuduar, Egypt, Hong Kong, India, Israel,Japan, Korea, Maylasia, New Zealand, Mexico, Peru, Philipines, Pakistan, Saudia Arabia, Singapore, Thailand, Taiwan, Viet Nam, South Africa and UK. |
| Initiated | 2012-08-07 |
| Classified | 2012-09-20 |
| Terminated | 2014-02-26 |
| Recall number | Z-2409-2012 |
| 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-2409-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62897/
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