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The Binding Site Group, Ltd. recalls Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a
Recalled January 25, 2017 · FDA recall Z-1018-2017 · The Binding Site Group
Hazard
Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position. · FDA Class II
Units
129 units
Sold at
Worldwide Distribution - US Nationwide in the states of: CA, VA, GA, PA, NJ, KY, NY, AR, NM, NC, AL, GA, MI, and the countries of Canada, China, Australia, Israel, Ireland, UK, Germany, Belgium, Italy, France, Czech republic, Spain, Portugal.
Description
Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
Product
Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia, and of pancreatic islet cell carcinoma.
Manufacturer(s)
The Binding Site Group, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →