Device 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.
Z-0002-2018
Product summary
- Event
- Event 78047
- Status
- Terminated
- Classification
- Class II
- Quantity
- 361 kits
- Official record key
device-enforcement:Z-0002-2018
Official wording
Reason: The high control for the kit is recovering low and may be out of range for assigned values.
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.
Derived failure modes
-
Unknown
The high control for the kit is recovering low and may be out of range for assigned values.