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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