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Abbott Laboratories recalls ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Cont
Recalled May 22, 2019 · FDA recall Z-1360-2019 · Abbott Laboratories
Hazard
Devices were delivered without the required dry ice. · FDA Class III
Units
3 units
Sold at
Distribution to Latvia.
Description
Devices were delivered without the required dry ice.
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.
Manufacturer(s)
Abbott Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →