Home / Recalls / The Binding Site Group, Ltd. / Z-0002-2018

Z-0002-2018 Class II Terminated

Recalled by The Binding Site Group, Ltd. — Birmingham, N/A

Recall Details

Product Type
Devices
Report Date
October 11, 2017
Initiation Date
August 23, 2017
Termination Date
February 21, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
361 kits

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.

Reason for Recall

The high control for the kit is recovering low and may be out of range for assigned values.

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.

Code Information

Lot #400900, Exp. 12/31/2017, UDI #05051700016421

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  • Z-1619-2020 Class II — C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)0 (April 25, 2019)
  • Z-0671-2020 Class II — Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein (February 19, 2019)
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