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Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitativ
Recalled September 9, 2020 · FDA recall Z-2927-2020 · Siemens Healthcare Diagnostics
Hazard
Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples · FDA Class II
Units
US: 1239 units OUS: 3387
Sold at
Nationwide
Description
Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
Product
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
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →