Device 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.
Z-2071-2020
Product summary
- Event
- Event 85492
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36
- Official record key
device-enforcement:Z-2071-2020
Official wording
Reason: A software issue that may affect the analyzer's result accuracy.
Code information: Analyzers running with software version 7.0 or 7.01
Distribution pattern: 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.
Derived failure modes
-
Device software or design
software issue