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 | Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe increased imprecision with low level patient samples |
| Product | IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # L2KTY2(D) Siemens Material Number (SMN): 10381647 |
| Quantity | 717 kits |
| Distribution | Nationwide Foreign: Argentina® Australia® Austria® Bahrain® Bangladesh® Belgium® Bolivia® BosniaHerzeg. Brazil® Bulgaria® Canada® Chile® Colombia® CostaRica® Croatia® Cyprus® CzechRepublic® DominicanRep. Ecuador® Egypt® Estonia® Finland® France® Georgia®… |
| Initiated | 2022-12-07 |
| Classified | 2023-01-11 |
| Recall number | Z-0949-2023 |
| 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-0949-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91310/
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