Abbott Laboratories recalls ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alini…

Recall date

April 9, 2019

Source

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

Recall number

Z-1361-2019

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

ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.