FDA-Device2019-10-23Class II

Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens

Siemens Healthcare Diagnostics, Inc.
Hazard

Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below

Sold states
Worldwide Distribution - US Nationwide Foreign: Argentina Australia Austria Bangladesh Belgium Brazil Bulgaria Canada Chile Colombia Czech Republic Denmark Ecuador Egypt Finland France Germany Greece Hungary India Indonesia Iran Ireland Israel Italy Japan Kuwait Latvia Malaysia Mexico Netherlands Nigeria Norway P.R. China Pakistan Philippines Poland Portugal Qatar Republic Korea Romania Russian Fed. Saudi Arabia Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay Vietnam
Affected count
1125 units
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0148-2020

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