Recall – Atellica Solution IVD System software issues

Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 1/29/2019
Class II


Atellica IM 1300 Analyzer; In-vitro diagnostic testing of clinical specimens; Siemens Material Number (SMN): 1066001

Product Usage: The Atellica Solution is a multi-component system for in-vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.

Recall Number: Z-0780-2019

Recall Number: Z-0781-2019

Recall Number: Z-0782-2019

Recall Number: Z-0783-2019


Multiple issues identified in the Atellica Solution System (Software V 1.14.2 and lower in the Atellica IM 1300 Analyzer, Atellica IM 1600 Analyzer, Atellica CH 930 Analyzer, and Atellica Sample Handler Prime).


Siemens Healthcare Diagnostics, Inc., Tarrytown, NY on 9/26/2018. Voluntary: Firm Initiated, recall is ongoing.

217 units

U.S. Nationwide and International

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT

Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.