Device 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

Z-2927-2020

July 24, 2020

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc.
Event: Event 86151
Status: Terminated
Classification: Class II
Quantity: US: 1239 units OUS: 3387
Official record key: device-enforcement:Z-2927-2020

Official wording

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

Code information: Lot # 20008BB UDI: 0084276803771920135BB21031010471067840; Lot #20035BC UDI:0084276803771920035BC20113010471067840; Lot #20135BB UDI: 0084276803771920008BB20110310471067840

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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