# FDA recall Z-2071-2020

> **The Binding Site Group, Ltd.** · Class II · device recall initiated 2020-04-09.

## 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.

## Reason for recall

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

## Distribution

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.

## Key facts

- **Recall number:** Z-2071-2020
- **Recalling firm:** The Binding Site Group, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-09
- **Report date:** 2020-05-27
- **Termination date:** 2022-08-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Birmingham, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2071-2020

## Citation

> AI Analytics. FDA recall Z-2071-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2071-2020. Source: US FDA. Licensed CC0.

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