Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its IMMAGE Immunochemistry Systems IgE Immunoglobulin E Reagent [Ref: 474620; All lots].
According to the manufacturer, the product does not meet its Rheumatoid Factor (RF) interference claim in low pools of IgE starting at an RF level of 376 IU/ml. The magnitude of change to IgE values of samples with RF levels above the interference threshold would not produce medically significant erroneous test results.
The manufacturer advised that Instruction for Use (IFUs) are located on the manufacturer website's Technical Documents section and affected users should follow the advice as indicated since the information supersedes previous claims and serves as current labeling until the revised IFUs are released.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 April 2021