FDAFDA · Food and drugs·Recall number Z-1018-2017
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.
Published January 25, 2017 · Recall initiated: May 13, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Binding Site Group, Ltd.
- Distributor
- 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.
- Lot
- 864000290243 864000290832 864000290244 864000290833 864000290330 864000290834 864000290447 864000290836 864000290448 864000290837 864000290449 864000290838 864000290452 864000290844 864000290826 864000290845 864000290827 864000290846 864000290828 864000290847 864000290831 864000290850
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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