Device product
Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.
Z-1926-2014
Product summary
- Event
- Event 66364
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1625
- Official record key
device-enforcement:Z-1926-2014
Official wording
Reason: Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.
Code information: Lot Number - 3DD007
Distribution pattern: Distribution: US Nationwide including Puerto Rico
Derived failure modes
-
Unknown
Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.