Recall Z-0002-2018 ยท DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
The Binding Site Group, Ltd.
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 adu
| Date | Aug 23, 2017 |
| Status | Terminated |
| Reason | The high control for the kit is recovering low and may be out of range for assigned values. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123256 | HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS The Binding Site Group , Ltd., Jul 3, 2013 |