Device, General Purpose, Microbiology, Diagnostic

What Is FDA Product Code LIB?

Device, General Purpose, Microbiology, Diagnostic is FDA product code LIB, Class 1, 21 CFR 866.2660.

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.

What Do the Recalls Say?

The FDA has recorded 13 recalls under this product code since 2007. None was by a company in China. The root cause the FDA records most often is Software design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.