# FDA recall Z-0477-2019

> **The Binding Site Group, Ltd.** · Class II · device recall initiated 2018-07-25.

## Product

Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S    The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.

## Reason for recall

After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve. Samples have been shown to be similarly affected.

## Distribution

U.S.: IL, WV, NE, SD, NY, IN, WA, MD, NJ, PA, NC, AR, FL, VA

## Key facts

- **Recall number:** Z-0477-2019
- **Recalling firm:** The Binding Site Group, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-25
- **Report date:** 2018-11-28
- **Termination date:** 2021-04-27

- **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-0477-2019

## Citation

> AI Analytics. FDA recall Z-0477-2019. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-0477-2019. Source: US FDA. Licensed CC0.

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