FDA-Device2019-05-22Class III
ARCHITECT STAT High Sensitive Troponin-I Controls - 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.
Abbott Laboratories
Hazard
Devices were delivered without the required dry ice.
Sold states
Distribution to Latvia.
Affected count
2 units
Manufactured in
100 Abbott Park Rd Bldg Ap8b, Abbott Park, IL, United States
Products
ARCHITECT STAT High Sensitive Troponin-I Controls - 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1359-2019Don't want to check this manually?
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