Device product
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
Z-0052-2021
Product summary
- Event
- Event 86374
- Status
- Terminated
- Classification
- Class II
- Quantity
- 533 US and 1822 OUS
- Official record key
device-enforcement:Z-0052-2021
Official wording
Reason: 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
Code information: Lot # EB0255 UDI: 00842768037726EB025520091110471068840
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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