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Recall Observatory FDA recall evidence

Device product

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 and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (¿g Eq/ml) can be determined by comparison to a standard curve.

Z-1496-2018

April 04, 2017

Class II

Product summary

Firm
Diagnostic Hybrids, Inc.
Event
Event 79629
Status
Terminated
Classification
Class II
Quantity
101 kits
Official record key
device-enforcement:Z-1496-2018

Official wording

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

Code information: Lot 084007

Distribution pattern: The products were distributed to the following US states: NY, TX, CO, UT. The products were distributed to the following foreign countries: Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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