FDA-Device2016-05-18Class II
Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.
Siemens Healthcare Diagnostics, Inc.
Hazard
Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days.
Sold states
Worldwide distribution and US including Puerto Rico and to the states of : TX, FL, CA, LA, DC, GA, IL, AR, WI, MI and MD.
Affected count
394
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1633-2016Don't want to check this manually?
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