FDA-Device2019-05-22Class III
ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
Abbott Laboratories
Hazard
Devices were delivered without the required dry ice.
Sold states
Distribution to Latvia.
Affected count
1 unit
Manufactured in
100 Abbott Park Rd Bldg Ap8b, Abbott Park, IL, United States
Products
ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1357-2019Don't want to check this manually?
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