FDA-Device2019-10-30Class II
Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
Siemens Healthcare Diagnostics, Inc.
Hazard
Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
Sold states
Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam
Affected count
166 total US: 15; OUS:151
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0205-2020Don't want to check this manually?
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