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GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS

ARKRAY USA, INC. · Model 540010 · UDI-DI 00015482540104

CGA

510(k) clearances

7,612

Adverse events (14 deaths)

Recalls

132

Facilities

Description

The GLUCOCARD Shine Test Strips are for use with the GLUCOCARD Shine Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is 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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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.