# FDA recall Z-0274-2022

> **The Binding Site Group, Ltd.** · Class II · device recall initiated 2021-10-15.

## Product

Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S  Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S

## Reason for recall

Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.

## Distribution

U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA.     O.U.S.: Canada

## Key facts

- **Recall number:** Z-0274-2022
- **Recalling firm:** The Binding Site Group, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-10-15
- **Report date:** 2021-12-01
- **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-0274-2022

## Citation

> AI Analytics. FDA recall Z-0274-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0274-2022. Source: US FDA. Licensed CC0.

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