medical Class II Updated 2020-09-09

Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista High Sensitivity Troponin I (TNIH) Flex reag

Recalled 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

Hazard / Issue

Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 20008BB UDI: 0084276803771920135BB21031010471067840; Lot #20035BC UDI:0084276803771920035BC20113010471067840; Lot #20135BB UDI: 0084276803771920008BB20110310471067840
View official government recall

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