FDA-Device2020-07-01Class II
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
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 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
927
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2404-2020Don't want to check this manually?
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