FDAAugust 19, 2020device
Dimension LOCI 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: RF627, SMN# 10471068
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed
What to do
FDA enforcement status: Terminated
Brands named
siemens healthcare diagnosticssiemenssiemens healthcare
Recall history
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