FDA-Device2020-09-09Class II
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 104471067
Siemens Healthcare Diagnostics, Inc.
Hazard
Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
Sold states
Nationwide
Affected count
US: 1239 units OUS: 3387
Manufactured in
500 Gbc Dr, N/A, Newark, DE, United States
Products
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 104471067
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2927-2020Don't want to check this manually?
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