Abbott Laboratories recalls ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARC…

Recall date

April 9, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1355-2019

FDA classification

Class III

Brand / firm

Abbott Laboratories

Sold / distributed

Distribution to Latvia.

Why it was recalled

Devices were delivered without the required dry ice.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.