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FDASeptember 11, 2014device

Human lgG4 Subclass kit for use on the Beckman Coulter AU" series 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 ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

binding sitebinding

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Human lgG4 Subclass kit for use on the Beckman Coulter AU" series 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 ... — Recall Details · AllClear