ReliOn™ Premier Blood Glucose Test Strips
WAL-MART STORES, INC. · Model 780050 / 780100 · UDI-DI 00194346219261
Description
ReliOn Premier Blood Glucose Test Strips are for use with the ReliOn Premier family of blood glucose meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. Alternative site testing (AST) should only be used during steady-state blood glucose conditions. The ReliOn Premier family of blood glucose monitoring systems are intended for self-testing outside the body (in vitro) by people with diabetes as an aid to monitor the effectiveness of diabetes control. They are not intended for use on neonates, and they are not for the diagnosis or screening of diabetes.
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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