Diagnostic Hybrids Inc recalls MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnosti…

Recall date

October 16, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0417-2015

FDA classification

Class II

Brand / firm

Diagnostic Hybrids Inc

Sold / distributed

Worldwide Distribution - USA, including AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, and WA; and, the countries of Canada, China, India, and Switzerland.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.