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

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

Recall Number: Z-0473-2021

REASON

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.

RECALLING FIRM/MANUFACTURER

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

VOLUME OF PRODUCT IN COMMERCE

US 392 units; OUS 449 units

DISTRIBUTION

U.S. Nationwide and International

Latest News!

Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
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  • How to perform software hazards analysis.
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