# FDA recall Z-1435-2020

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2020-01-06.

## Product

Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - 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.

## Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

## Key facts

- **Recall number:** Z-1435-2020
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-06
- **Report date:** 2020-03-11
- **Termination date:** 2022-07-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1435-2020

## Citation

> AI Analytics. FDA recall Z-1435-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1435-2020. Source: US FDA. Licensed CC0.

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