Z-0002-2018Class II

Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label...

Name: Z-0002-2018 Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label...
Creator: The Binding Site Group, Ltd.
Published: 2017-08-23
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2017-08-23 / Terminated

FDA source

The Binding Site Group, Ltd. began a recall of 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... on 2017-08-23. FDA classified it as Class II and gives the reason as "The high control for the kit is recovering low and may be out of range for assigned values". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0002-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-23
Posted: 2017-10-04
Terminated: 2019-02-21
Recalling firm: The Binding Site Group Ltd.
Product: 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.
Product code: DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Reason for recall: The high control for the kit is recovering low and may be out of range for assigned values.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 361 kits
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.
Product codes and lots: Lot #400900, Exp. 12/31/2017, UDI #05051700016421

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0002-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0002-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-11	2017-10-04

Product code DEM

K123256Class IIHuman Alpha-1 Antitrypsin Kit SpaplusThe Binding Site Group , Ltd. / cleared 2013-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)