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U.S. Department of Health and Human Services

Class 2 Device Recall Human Alpha1Antitrypsin Kit

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 Class 2 Device Recall Human Alpha1Antitrypsin Kitsee related information
Date Initiated by FirmAugust 23, 2017
Create DateOctober 04, 2017
Recall Status1 Terminated 3 on February 21, 2019
Recall NumberZ-0002-2018
Recall Event ID 78047
510(K)NumberK123256 
Product Classification Alpha-1-antitrypsin, antigen, antiserum, control - Product Code DEM
ProductHuman 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.
Code Information Lot #400900, Exp. 12/31/2017, UDI #05051700016421
Recalling Firm/
Manufacturer		 The Binding Site Group, Ltd.
8 Calthorpe Road
Birmingham United Kingdom
For Additional Information Contact
858-453-9177
Manufacturer Reason
for Recall		The high control for the kit is recovering low and may be out of range for assigned values.
FDA Determined
Cause 2		Under Investigation by firm
ActionBinding 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.
Quantity in Commerce361 kits
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DEM
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