Z-2927-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2020
- Initiation Date
- July 24, 2020
- Termination Date
- June 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 1239 units OUS: 3387
Product Description
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
Reason for Recall
Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
Distribution Pattern
Nationwide
Code Information
Lot # 20008BB UDI: 0084276803771920135BB21031010471067840; Lot #20035BC UDI:0084276803771920035BC20113010471067840; Lot #20135BB UDI: 0084276803771920008BB20110310471067840