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.
This recall has been terminated (originally issued August 23, 2017).
- Company
- The Binding Site Group, Ltd.
- Recall Initiated
- August 23, 2017
- Terminated
- February 21, 2019
- Recall Number
- Z-0002-2018
- Quantity
- 361 kits
- Firm Location
- Birmingham United Kingdom
- Official Source
- View on FDA website ↗
Reason for Recall
The high control for the kit is recovering low and may be out of range for assigned values.
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.
Lot / Code Info
Lot #400900, Exp. 12/31/2017, UDI #05051700016421
Root Cause
Under Investigation by firm
Action Taken
Binding Site sent an Field Safety Notice dated August 24, 2017, explaining the reason for recall and requesting the direct account and their customer to remove the affected kits from inventory and dispose of them. The direct account and their customers were instructed to circulate the field safety notice to other persons who use the product within their organization. A response form, to be returned via email, was enclosed for completion to indicate the number of kits discarded. For further questions, please call (858) 453-9177.