FDA-Device2017-10-11Class IIPROCESSING DEFECT
The Binding Site Alpha-1-Antitrypsin Kit recalled for control value accuracy issue
OTHERCA
Check The Binding Site antitrypsin test kit lot #400900
The Binding Site Group's Alpha-1-Antitrypsin Kit (Product #NK034.S) for laboratory blood testing may produce inaccurate results. The high control sample in affected kits is not performing correctly, which could affect test reliability. This kit is used to measure a protein in blood that helps diagnose liver and lung conditions.
- If your laboratory uses this kit, verify your lot number matches #400900 with expiration 12/31/2017
- Contact The Binding Site Group if you have this lot number
- Do not use affected kits for patient testing until you receive replacement or instructions
Hazard
The high control for the kit is recovering low and may be out of range for assigned values.
Sold states
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.
Affected count
361 kits
Manufactured in
8 Calthorpe Road, N/A, Birmingham, N/A, United Kingdom
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2018More The Binding Site Group, Ltd. recalls
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