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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:122157

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.

Official recall number

Z-1926-2014

Evidence summary

Product code
JIT
Recall status
Terminated
Event initiated
September 17, 2013
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1926-2014