Multiple Use Blood Lancet for Single Patient Use Only

What Is This Device?

A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

What Is FDA Product Code QRL?

Multiple Use Blood Lancet For Single Patient Use Only is FDA product code QRL, Class 2, 21 CFR 878.4850.

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

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 12 clearances under this code; the FDA took a median of 67 days from receipt to decision on them. 3 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2025. None was by a company in China. The root cause the FDA records most often is Error in labeling (1).

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