How Is LXG Classified?
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use is FDA product code LXG, Class 1, 21 CFR 862.2050.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.
What Has Gone Wrong With It?
The FDA has recorded 28 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Software design (3), Device Design (2) and Labeling design (2).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.