Z-0052-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 14, 2020
- Initiation Date
- August 19, 2020
- Termination Date
- August 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 533 US and 1822 OUS
Product Description
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
Reason for Recall
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
Distribution Pattern
US Nationwide distribution.
Code Information
Lot # EB0255 UDI: 00842768037726EB025520091110471068840