The Binding Site Group, Ltd.: Medical Device Recall in 2020 - (Recall #: Z-2071-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 9, 2020

Date Posted: May 27, 2020

Recall Number: Z-2071-2020

Event ID: 85492

Reason for Recall:

A software issue that may affect the analyzer's result accuracy.

Status: Terminated

Product Quantity: 36

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.

Voluntary or Mandated:

Voluntary: Firm initiated