# FDA recall Z-1497-2018

> **Diagnostic Hybrids, Inc.** · Class III · device recall initiated 2015-11-03.

## Product

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.

## Reason for recall

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

## Distribution

Worldwide Distribution - USA (nationwide) to the states of :  CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.

## Key facts

- **Recall number:** Z-1497-2018
- **Recalling firm:** Diagnostic Hybrids, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2015-11-03
- **Report date:** 2018-05-02
- **Termination date:** 2020-08-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athens, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1497-2018

## Citation

> AI Analytics. FDA recall Z-1497-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1497-2018. Source: US FDA. Licensed CC0.

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