Diagnostic Hybrids, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1496-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 4, 2017

Date Posted: May 2, 2018

Recall Number: Z-1496-2018

Event ID: 79629

Reason for Recall:

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

Status: Terminated

Product Quantity: 101 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated