medical Class III Updated 2019-05-22

Abbott Laboratories recalls ARCHITECT STAT High Sensitive Troponin-I Controls - Product

Recalled Product

ARCHITECT STAT High Sensitive Troponin-I Controls - 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.


Hazard / Issue

Devices were delivered without the required dry ice.

Issued by

FDA

Distribution: Distribution to Latvia.
Lot/Code Info: LN 3P25-11; Lot 94347UIOO
View official government recall

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