# FDA recall Z-0943-2021

> **The Binding Site Group, Ltd.** · Class II · device recall initiated 2020-11-18.

## Product

Optilite Freelite Mx Kappa Free Kit  REF LK016.M.OPT.A

## Reason for recall

Due to customer complaints of positive bias impacting quality control.  The high and low level controls are demonstrating a positive bias compared to assigned values.

## Distribution

U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT.    O.U.S.: Not provided

## Key facts

- **Recall number:** Z-0943-2021
- **Recalling firm:** The Binding Site Group, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-18
- **Report date:** 2021-02-10
- **Termination date:** 2024-12-23

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0943-2021

## Citation

> AI Analytics. FDA recall Z-0943-2021. Retrieved 2026-09-22 from https://api.ai-analytics.org/recall/Z-0943-2021. Source: US FDA. Licensed CC0.

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