Reported May 27, 2020 · Terminated

The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite…

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 · N/A

Is this the product you have?

  • The Optilite Clinical Chemistry Analyzer. IVD
  • Model NumberIE700
  • UDI-05051700017176 - Product UsageThe Optilite 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
Lot codes and dates
  • Analyzers running with software version 7.0 or 7.01
Amount recalled
36

Where it was sold

Why it was recalled

A software issue that may affect the analyzer's result accuracy.

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 Aug 19, 2022 · Data as of Sep 19, 5:30 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.