FDA-Device2021-10-27Class II
Atellica IM 1600 Analyzer, SMN 11066000
Siemens Healthcare Diagnostics, Inc
Hazard
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
Sold states
Domestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX UT VA WA WI WY. Foreign distribution worldwide.
Affected count
1733
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
Atellica IM 1600 Analyzer, SMN 11066000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0125-2022Don't want to check this manually?
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