# FDA recall Z-0002-2018

> **The Binding Site Group, Ltd.** · Class II · device recall initiated 2017-08-23.

## Product

Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S.  The firm name on the label is The Binding Site Group Ltd., Birmingham, UK.    Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.

## Reason for recall

The high control for the kit is recovering low and may be out of range for assigned values.

## Distribution

Worldwide Distribution - US Distribution to the state of CA., and to the countries of : United Kingdom, Germany, France, Czech Republic, Belgium, Panama, Bulgaria, Iran, Argentina, Turkey Romania, Colombia, and Saudi Arabia.

## Key facts

- **Recall number:** Z-0002-2018
- **Recalling firm:** The Binding Site Group, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-23
- **Report date:** 2017-10-11
- **Termination date:** 2019-02-21

- **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-0002-2018

## Citation

> AI Analytics. FDA recall Z-0002-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0002-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*