FDA-Device2020-10-14Class II
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
Siemens Healthcare Diagnostics, Inc.
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
Sold states
US Nationwide distribution.
Affected count
533 US and 1822 OUS
Manufactured in
500 Gbc Dr, N/A, Newark, DE, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0052-2021Don't want to check this manually?
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