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