# FDA recall Z-2027-2021

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2021-05-13.

## Product

Atellica IM 1300 Analyzer -  multi-component system for in vitro diagnostic testing of clinical specimens  SMN 11066001

## Reason for recall

Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.

## Distribution

Nationwide  Foreign:  Country Name  Algeria  Argentina  Australia  Austria  Bahrain  Bangladesh  Belgium  Brazil  Bulgaria  Burkina Faso  Canada  Chile  Colombia  Croatia  Cura¿ao  Cyprus  Czech Republic  Denmark  Ecuador  Egypt  Estonia  Finland  France  Germany  Greece  Hungary  India  Indonesia  Iraq  Ireland  Israel  Italy  Japan  Kenya  Kuwait  Latvia  Libya  Lithuania  Malaysia  Mexico  Morocco  Netherlands  New Zealand  Norway  Oman  P.R. China  Pakistan  Peru  Philippines  Poland  Portugal  Qatar  Republic Korea  Romania  Russian Fed.  Saudi Arabia  Singapore  Slovakia  Slovenia  South Africa  Spain  Sweden  Switzerland  Taiwan  Thailand  Turkey  U.A.E.  Uganda  Ukraine  United Kingdom  Uruguay  Vatikancity  Vietnam

## Key facts

- **Recall number:** Z-2027-2021
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-05-13
- **Report date:** 2021-07-14

- **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-2027-2021

## Citation

> AI Analytics. FDA recall Z-2027-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2027-2021. Source: US FDA. Licensed CC0.

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