Devices

Device Recall Human Alpha1Antitrypsin Kit

Model / Serial
Lot #400900, Exp. 12/31/2017, UDI #05051700016421
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
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.
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.
Manufacturer
The Binding Site Group, Ltd.
1 Event
- Recall of Device Recall Human Alpha1Antitrypsin Kit

Manufacturer

The Binding Site Group, Ltd.

Manufacturer Address
The Binding Site Group, Ltd., 8 Calthorpe Road, Birmingham United Kingdom
Manufacturer Parent Company (2017)
Cidron Iugo Sarl
Source
USFDA

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