Abbott Laboratories recalls ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Cont…

Recall date

April 9, 2019

Source

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

Recall number

Z-1360-2019

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 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.