Multi-Analyte Controls Unassayed

What Is This Device?

A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (unassayed) for blood gases, electrolytes, enzymes, multianalytes, single (specified) analytes, or urinalysis controls.

What Is FDA Product Code OHQ?

Multi-Analyte Controls Unassayed is FDA product code OHQ, Class 1, 21 CFR 862.1660.

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 24 recalls under this product code since 2017. None was by a company in China. The root causes the FDA records most often are Process control (9), Process design (5) and Material/Component Contamination (2).

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