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FDAApril 4, 2017device

MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples ...

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

The hazard

There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.

What to do

FDA enforcement status: Terminated

Brands named

diagnostic hybridsdiagnostic

Recall history

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

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