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AUVON

Shenzhen Yuwen E-Commerce Co., Ltd. · Model LD11000P2 · UDI-DI 06971292001553

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510(k) clearances

238

Adverse events

Recalls

Facilities

Description

The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of. This system is for use only on a single patient in a home setting. This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

Recalls

Date	Firm	Reason
2025-07-25	Home Health US, Incorporated	Due to incorrect/lack of Unique Device Identifier (UDI) codes.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.