# FDA recall Z-2030-2021

> **The Binding Site Group, Ltd.** · Class II · device recall initiated 2021-05-20.

## Product

FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE,  UDI: 05051700012096

## Reason for recall

The high and low level "Quality  Controls" demonstrate  a positive bias of approximately 10% compared to assigned values.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of CA, GA, FL, MA, MO, MI, WA, NY, PA, MN, AL, MD, OK, NE, IN, ID, OH, TX, HI, DC and the countries of Canada, Australia,  Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, France, Germany,  Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Switzerland, United Kingdom, Argentina, Egypt, GUADELOUPE, HONG KONG, India, Iran,  Israel, Korea, Lebanon, Malaysia, Morocco, Oman, Singapore, Taiwan, Tunisia, Vietnam.

## Key facts

- **Recall number:** Z-2030-2021
- **Recalling firm:** The Binding Site Group, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-20
- **Report date:** 2021-07-14
- **Termination date:** 2025-02-04

- **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-2030-2021

## Citation

> AI Analytics. FDA recall Z-2030-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2030-2021. Source: US FDA. Licensed CC0.

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