Recall Z-1073-2017— The Binding Site Group, Ltd.

Name: FDA recall Z-1073-2017
Creator: U.S. Food and Drug Administration
Published: 2014-09-11

Class II · Terminated

Class II FDA medical device recall by The Binding Site Group, Ltd., initiated 2014-09-11, terminated 2017-05-03. It names one FDA 510(k) clearance: K982100. Product: MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. Reason: Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results..

Recalling firm: The Binding Site Group, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2014-09-11
Terminated: 2017-05-03
Firm location: Birmingham, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K982100 — IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITSThe Binding Site, Ltd.·cleared 1999-12-20

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

MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents

Reason for recall

Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

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