Recall – Clinical chemistry analyzer inaccurate results with certain software

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

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