Reported Jan 25, 2017 · Terminated
Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a…
The Binding Site Group, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Binding Site Group, Ltd. · 8 Calthorpe Road · Birmingham · N/A
Is this the product you have?
- Optilite Analyser
- Product CodeIE700
- Product UsageThe 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
- Lot codes and dates
864000290243864000290832864000290244864000290833864000290330864000290834864000290447864000290836864000290448864000290837864000290449864000290838864000290452864000290844864000290826864000290845864000290827864000290846864000290828864000290847864000290831864000290850
- Amount recalled
- 129 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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