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 | Homocysteine Assay May Cause Elevated Results in the Folate Assay |
| Product | Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366 |
| Quantity | 10,928 kits |
| Distribution | Nationwide Foreign: Armenia® Austria® Bahrain® Belgium® BosniaHerzeg. CzechRepublic® Denmark® Egypt® France® Georgia® Germany® Greece® Hungary® Iran® Ireland® Israel® Italy® Jordan® Lithuania® Nepal® Netherlands® Norway® Paki… |
| Initiated | 2019-07-22 |
| Classified | 2020-01-21 |
| Terminated | 2025-02-14 |
| Recall number | Z-0830-2020 |
| 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-0830-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84078/
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