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 anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use (IFU). |
| Product | SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399 |
| Quantity | 10414 kits |
| Distribution | Nationwide Foreign: Belgium® Croatia® CzechRepublic® Denmark® France® Germany® Greece® Ireland® Italy® Poland® Portugal® Slovakia® Spain® Switzerland® Turkey® BOGOTA QUARRY BAY, HONG KONG YANGON … |
| Initiated | 2018-12-07 |
| Classified | 2019-04-26 |
| Terminated | 2020-04-27 |
| Recall number | Z-1234-2019 |
| 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-1234-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82521/
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