medical Class II Updated 2020-05-27

The Binding Site Group, Ltd. recalls The Optilite Clinical Chemistry Analyzer. IVD. Model Number:

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Analyzers running with software version 7.0 or 7.01
View official government recall

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