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Devices
Device Recall Contour Next Control Solution for Contour Next Blood Glucose Test System
Model / Serial
SKU# 7314 (Level 2) and SKU# 7315 (Level 1) All Lots
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Switzerland, UK, Albania, Azerbaijan, Bulgaria, Czech Republic, Estonia, Hungary, Korea, Latvia, Lithuania, Philippines, Romania, Serbia, Slovakia, and Thailand.
Product Description
Contour Next Control Solution for Contour Next Blood Glucose Test System. || Liquid quality control solution. Plastic bottle, 2.5mL. || Indicated for use with fresh fingertip capillary whole blood samples.
Manufacturer
Bayer Healthcare, LLC
1 Event
Recall of Device Recall Contour Next Control Solution for Contour Next Blood Glucose Test System
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Manufacturer
Bayer Healthcare, LLC
Manufacturer Address
Bayer Healthcare, LLC, 430 S Beiger St, Mishawaka IN 46544-3207
Manufacturer Parent Company (2017)
Bayer AG
Source
USFDA
Language
English
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