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 Bb Plus EIA is packaged as a kit which Recalled by Diagnostic Hybrids Inc Due to Samples are quantitating incorrectly, with approximately 50% higher...

Date: October 16, 2014
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 Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.

Quantity: 171

Why Was This Recalled?

Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.

Where Was This Sold?

This product was distributed to 11 states: AL, CO, CT, FL, KY, MN, NV, NC, OH, PA, WA

Affected (11 states)Not affected

About Diagnostic Hybrids Inc

Diagnostic Hybrids Inc has 2 total recalls tracked by RecallDetector.

Related Recalls

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