FDAFDA · Food and drugs·Recall number Z-0002-2018
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.
Published October 11, 2017 · Recall initiated: August 23, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The high control for the kit is recovering low and may be out of range for assigned values.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- The Binding Site Group, Ltd.
- Distributor
- 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.
- Lot
- Lot #400900, Exp. 12/31/2017, UDI #05051700016421
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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