Recall – IM Analyzer software update resets custom settings to default values

Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 11/25/2020
Class II


Atellica IM 1300 Analyzer – Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001

Recall Number: Z-0473-2021


Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values.


Siemens Healthcare Diagnostics, Inc. on 10/26/2020. Voluntary:  Firm Initiated recall is ongoing.


US 392 units; OUS 449 units


U.S. Nationwide and International

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

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