Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

MicroVue CIC-C1q EIA Recalled by Diagnostic Hybrids, Inc. Due to A component of the kit was found to...

Date: November 3, 2015
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. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.

Quantity: 19 kits

Why Was This Recalled?

A component of the kit was found to contain bacterial contamination.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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