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
    • 864000290243
    • 864000290832
    • 864000290244
    • 864000290833
    • 864000290330
    • 864000290834
    • 864000290447
    • 864000290836
    • 864000290448
    • 864000290837
    • 864000290449
    • 864000290838
    • 864000290452
    • 864000290844
    • 864000290826
    • 864000290845
    • 864000290827
    • 864000290846
    • 864000290828
    • 864000290847
    • 864000290831
    • 864000290850
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 17, 2017 · Data as of Sep 19, 6:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.