# FDA recall Z-1499-2018

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

## Product

MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029.  An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.

## 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-1499-2018
- **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-1499-2018

## Citation

> AI Analytics. FDA recall Z-1499-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1499-2018. Source: US FDA. Licensed CC0.

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