Atellica IM Humidity Pack — Class II medical device recall Z-1436-2020
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2020-03-11, distributed nationwide. A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
| Recall number | Z-1436-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2020-01-06 |
| Classified | 2020-03-04 |
| Reported by FDA | 2020-03-11 |
| Terminated | 2022-07-11 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00630414243726 |
| Lot numbers | 0010 |
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.
Reason for recall
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1436-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.