Fixative, Formalin-Containing

What Is FDA Product Code LDY?

Fixative, Formalin-Containing is FDA product code LDY, Class 1, 21 CFR 864.4010.

What Does It Take to Sell It in the United States?

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 7 recalls under this product code since 2014. None was by a company in China. 7 are Class I, the most serious grade.

The root cause the FDA records most often is Mixed-up of materials/components (7). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.