Abbott Laboratories recalls ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the A…

Recall date

April 9, 2019

Source

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

Recall number

Z-1358-2019

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 Intact PTH Calibrators - 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.