Abbott Laboratories recalls ARCHITECT STAT High Sensitive Troponin-I Calibrators - Produ
Recalled Product
ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.
Hazard / Issue
Devices were delivered without the required dry ice.
Issued by
FDA
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