Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 Recalled by The Binding Site Group, Ltd. Due to A software issue that may affect the analyzer's...

Date: April 9, 2020
Company: The Binding Site Group, Ltd.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact The Binding Site Group, Ltd. directly.

Affected 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.

Quantity: 36

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About The Binding Site Group, Ltd.

The Binding Site Group, Ltd. has 28 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report