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1 The agency also called out the company for failing to identify potential risk to patients from a falsely low test result.
2 Prozone is a known phenomenon affecting immunoassays causing falsely low or negative results when excess target is present in the test system.
3 Since the glycated abnormal Hb emerged at the same position as did HbF on high performance liquid chromatography, the HbA1C value was falsely low .
4 In the Form 483 on Thursday, FDA also noted that the company failed to adequately evaluate the risk of the test for falsely low results.
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