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 | Ongoing |
| Reason | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| Product | ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10331250 Siemens Material Number (SMN): 10325366 |
| Quantity | 124 kits |
| Distribution | Nationwide Foreign: Albania® Austria® Bahrain® Belgium® BosniaHerzeg. Bulgaria® Croatia® Curaao,StEus Cyprus® CzechRepublic® Denmark® Estonia® Finland® France® Georgia® Germany® Greece® Hungary® Iran® Ireland® Israel® Italy® Jordan® Kenya®… |
| Initiated | 2023-01-09 |
| Classified | 2023-02-21 |
| Recall number | Z-1154-2023 |
| 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-1154-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91522/
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