FDA-Device2020-05-27Class II
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.
The Binding Site Group, Ltd.
Hazard
A software issue that may affect the analyzer's result accuracy.
Sold states
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.
Affected count
36
Manufactured in
8 Calthorpe Road, N/A, Birmingham, N/A, United Kingdom
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2071-2020Don't want to check this manually?
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