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 | A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. |
| Product | Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Humidity packs maintain reagent compartment humidity between 70100%. The operator loads 7 empty humidity packs initially. |
| Quantity | N/A |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| Initiated | 2020-01-06 |
| Classified | 2020-03-04 |
| Terminated | 2022-07-11 |
| Recall number | Z-1436-2020 |
| 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-1436-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84823/
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