Class III — Low Risk

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

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

Quantity: 72 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.

Related Recalls

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