FDA-Device2020-07-01Class II
Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
Siemens Healthcare Diagnostics, Inc.
Hazard
Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.
Sold states
Worldwide distribution including to the following states: Florida, New Jersey, New York, California, Arizona, Colorado, Pennsylvania, Virginia, Ohio, Texas, Alabama, Nebraska, Wisconsin, Montana, Kentucky, Washington DC, Massachusetts, North Carolina, Georgia, Louisiana, Kansas, South Carolina, Tennessee, Iowa, Rhode Island, South Dakota, New Hampshire, Maryland, Oregon, Indiana, Idaho, Connecticut, Puerto Rico, West Virginia, Washington, Illinois, Utah, Maine, Minnesota, Wyoming, Nevada, Michigan, Missouri, and New Mexico.
Affected count
1329
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2405-2020Don't want to check this manually?
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