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Recall Observatory FDA recall evidence

Device product

Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM 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

Z-1067-2017

September 11, 2014

Class II

Product summary

Firm
The Binding Site Group, Ltd.
Event
Event 76041
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1067-2017

Official wording

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

Code information: All lots.

Distribution pattern: Worldwide Distribution - US including n FL, OH, TN, MN, NW, MI, CA. and Internationally to Canada, France, UK, Spain, Germany, Czech Republic, Belgium, Italy, Australia, Brazil, Chile, China, Costa Rica, Kuwait, New Zealand, Oman, Pakistan, Portugal, Sweded, Taiwan, and Turkey.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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