Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MicroVue CIC-C1q EIA Recalled by Diagnostic Hybrids, Inc. Due to There is a potential for the slope of...

Date: April 4, 2017
Company: Diagnostic Hybrids, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Diagnostic Hybrids, Inc. directly.

Affected Products

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.

Quantity: 101 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 4 states: CO, NY, TX, UT

Affected (4 states)Not affected

About Diagnostic Hybrids, Inc.

Diagnostic Hybrids, Inc. has 6 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report