Recall Z-0002-2018— The Binding Site Group, Ltd.

Name: FDA recall Z-0002-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-23

Class II · Terminated

Class II FDA medical device recall by The Binding Site Group, Ltd., initiated 2017-08-23, terminated 2019-02-21. It names one FDA 510(k) clearance: K123256. 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.. Reason: The high control for the kit is recovering low and may be out of range for assigned values..

Recalling firm: The Binding Site Group, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2017-08-23
Terminated: 2019-02-21
Firm location: Birmingham, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K123256 — HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUSThe Binding Site Group , Ltd.·cleared 2013-07-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.