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AUVON

Shenzhen Yuwen E-Commerce Co., Ltd. · Model TS3000001 · UDI-DI 06971292001607

FMK

510(k) clearances

14,104

Adverse events (2 deaths)

Recalls

158

Facilities

Description

The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of capillary whole blood glucose values. This analysis employs the enzyme glucose oxidase and is based on advanced biosensor technology that is specific for -D-glucose measurement. The test strips are designed in such a way that when the blood is applied to the edge of reaction zone, the glucose oxidase triggers the oxidation of glucose in the blood. The intensity of the electrons formed is measured by the meter and correlates well with the concentration of glucose in the blood sample.

Recalls

Date	Firm	Reason
2021-03-16	Cardinal Health Inc.	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
2021-03-16	Cardinal Health Inc.	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
2021-03-16	Cardinal Health Inc.	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
2021-03-16	Cardinal Health Inc.	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
2013-08-19	Roche Diagnostics Operations, Inc.	Internal Roche inspections have revealed that after the lancet is used for a finger stick, the needle may not fully retract back within the lancet drum or back into the cap. This a
2013-07-10	Becton Dickinson & Company	The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.
2013-07-03	KooJoo Trading Company	Lancets were not sterilized within the dose range established by sterilization validation.
2009-05-13	Roche Diagnostics Corp.	The lancet cap may be missing, which could result in an unintended lancet stick to the user.
2008-08-27	Sarstedt Inc	The product from this lot may not retract the lancet into the safe position inside the lancet body after the trigger is actuated.
2008-07-18	Facet Technologies	The Alternate Site Cap was not included in the package as indicated on the labeling.

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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.