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The Binding Site Group, Ltd. recalls The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Cli
Recalled May 27, 2020 · FDA recall Z-2071-2020 · The Binding Site Group
Hazard
A software issue that may affect the analyzer's result accuracy. · FDA Class II
Units
36
Sold at
US Nationwide distribution including in the states of AL, AR, CA, FL, IL, IN, KS, KY, MA, MN, NC, NE, OH, PA, TX and VA.
Description
A software issue that may affect the analyzer's result accuracy.
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.
Manufacturer(s)
The Binding Site Group, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →