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# Arkray Recalls Class 1 Recall of Glucose Test Strips
- URL: https://www.fdaweb.com/arkray-recalls-class-1-recall-of-glucose-test-strips/
- Published: 2016-01-29T12:00:00.000Z
- Updated: 2026-09-15T02:31:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134610

> Arkray Factory has begun a Class 1 recall of its SpotChem II Test Strips due to inaccurate blood sugar readings. The reagent test stripa are used to glucose levels in blood samples, and are used with the SpotChem EZ analyzer.  
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> A [recall notice](http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm483760.htm?ref=fdaweb.com) says the strips are falsely showing low blood glucose when the true levels are above 265 mg/dL, and there is a risk that a health care provider would not diagnose hyperglycemia (high blood sugar) including diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in a timely manner and fail to treat elevated blood glucose levels.