medical Class II Updated 2020-04-15

Abbott Laboratories, Inc recalls ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clin

Recalled Product

ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a component and it is used on all ARCHITECT Clinical Chemistry systems to mix the sample with the reagent inside of the cuvettes.


Hazard / Issue

Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result of the mixer blade missing, the sample and reagent are inadequately mixed.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: LN 09D59-01, LN 09D59-02, LN 09D59-03
View official government recall

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