The Binding Site Group, Ltd.: Medical Device Recall in 2017 - (Recall #: Z-0002-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 23, 2017

Date Posted: October 11, 2017

Recall Number: Z-0002-2018

Event ID: 78047

Reason for Recall:

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

Status: Terminated

Product Quantity: 361 kits

Code Information:

Lot #400900, Exp. 12/31/2017, UDI #05051700016421

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated