Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser Recalled by The Binding Site Group, Ltd. Due to The high control for the kit is recovering...

Date: August 23, 2017
Company: The Binding Site Group, Ltd.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact The Binding Site Group, Ltd. directly.

Affected Products

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.

Quantity: 361 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

About The Binding Site Group, Ltd.

The Binding Site Group, Ltd. has 28 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report