Recall – Atellica Solution IVD System software issues

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

PRODUCT

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

REASON

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).

RECALLING FIRM/MANUFACTURER

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

VOLUME OF PRODUCT IN COMMERCE
217 units

DISTRIBUTION
U.S. Nationwide and International

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.