Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0474-2021·Announced 2020-11-25

Siemens Atellica IM 1600 Analyzer Recalled for Custom Settings Reset

Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers because scanning a new kit lot may reset custom settings to defaults.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a functional software defect that resets settings, which fits the criteria for a moderate severity issue without reported harm.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the Atellica IM 1600 Analyzer, an automated immunoassay analyzer used for in vitro diagnostic tests on clinical specimens. The recall involves units with software version V1.23.1 or lower. The distribution was worldwide, including the United States and numerous international locations.

The recall is due to a software issue where scanning a 2D Master Curve and Test Definition (TDef) barcode for a new kit lot of reagent may cause customer-defined settings for that assay to reset to default values. This occurs when the TDef version is newer than the version currently on the system. No specific injuries or illnesses have been reported in the source text.

Healthcare facilities and users of the Atellica IM 1600 Analyzer should contact Siemens Healthcare Diagnostics for instructions on how to address the software issue. The recall number is Z-0474-2021.

The recalled product

Product: Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostic Equipment
Hazard: software-defect
settings-reset

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Software version: V1.23.1 or lower UDI: 00630414002026

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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