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.
Check against the official notice below — it lists the full affected range.
The Binding Site Group, Ltd. is recalling 361 kits of Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser (Product #NK034.S, Lot #400900, expiring 12/31/2017). The recall was initiated because the high control for the kit is recovering low and may be out of range for assigned values. The affected kits were distributed worldwide, including to California in the United States and to the United Kingdom, Germany, France, Czech Republic, Belgium, Panama, Bulgaria, Iran, Argentina, Turkey, Romania, Colombia, and Saudi Arabia.
The recall notice does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The high control for the kit is recovering low and may be out of range for assigned values.
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. Quantity: 361 kits Lot/code info: Lot #400900, Exp. 12/31/2017, UDI #05051700016421
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.