# FDA recall Z-1619-2020

> **The Binding Site Group, Ltd.** · Class II · device recall initiated 2019-04-25.

## Product

C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,

## Reason for recall

A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected

## Distribution

U.S.: FL

## Key facts

- **Recall number:** Z-1619-2020
- **Recalling firm:** The Binding Site Group, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-25
- **Report date:** 2020-04-08
- **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-1619-2020

## Citation

> AI Analytics. FDA recall Z-1619-2020. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1619-2020. Source: US FDA. Licensed CC0.

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