AUVON
Shenzhen Yuwen E-Commerce Co., Ltd. · Model DS-W · UDI-DI 06971292007012
Description
The DS-W Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The DS-W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The DS-W Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The DS-W Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The DS-W Draw-in Blood Glucose Test Strips are for use with the DS-W Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-12 | HemoCue AB | Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not ha |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2024-03-01 | Alere San Diego, Inc. | There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor |
| 2023-09-06 | Randox Laboratories Ltd. | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may |
| 2023-09-06 | Randox Laboratories Ltd. | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may |
| 2023-09-06 | Randox Laboratories Ltd. | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may |
| 2022-08-16 | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. | Incorrect instructions for use were packaged into the final product. |
| 2022-06-24 | Alere San Diego, Inc. | Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations gre |
| 2020-08-28 | Siemens Healthcare Diagnostics Inc | Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hyp |
| 2019-09-18 | Medline Industries Inc | Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips. |
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