FDA recall Z-2927-2020

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2020-07-24

Report date

2020-09-09

Termination date

2023-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Newark, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2927-2020