Agency classClass IIOur severity:High FDA (Devices)·Z-0473-2021·Announced 2020-11-25

Siemens Atellica IM 1300 Analyzer Recalled for Test Definition Scanning Issues

Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers because scanning specific test definitions may reset custom settings, causing inaccurate test results.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves inaccurate diagnostic results (falsely low or high) which could lead to incorrect clinical decisions, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the Atellica IM 1300 Analyzer, an automated immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. The recall affects units with software version V1.23.1 or lower. The issue involves the scanning of Test Definitions (TDef); when a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned, and the TDef version is newer than the version currently on the system, some customer-defined settings for that assay may reset to default values.

This malfunction can cause falsely low or high test results. The recall covers 392 units in the United States and 449 units in other countries. Distribution was worldwide, including the United States and numerous international locations such as Canada, the United Kingdom, Germany, and Japan.

Healthcare facilities and users of these analyzers should contact Siemens Healthcare Diagnostics for further instructions on how to address the software issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostic Equipment
Hazard: inaccurate-results
software-defect

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: 00630414007960

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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