medical Class II Updated 2019-02-06

Siemens Healthcare Diagnostics, Inc. recalls Atellica Sample Handler Prime. In vitro diagnostic testing o

Recalled Product

Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - 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.


Hazard / Issue

Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atellica¿ Sample Handler Prime

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software in V 1.14.2 and lower.
View official government recall

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