Company: The Binding Site Group, Ltd.
Date of Enforcement Report: 6/10/2020
Class II
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.
Recall Number: Z-2071-2020
REASON
A software issue that may affect the analyzer’s result accuracy.
RECALLING FIRM/MANUFACTURER
The Binding Site Group, Ltd. on 4/9/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
36
DISTRIBUTION
US Nationwide