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

Recalled September 9, 2015 · FDA recall Z-0417-2015 · Diagnostic Hybrids

Hazard

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

Units

171

Sold at

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.

Description

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

Product

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

Manufacturer(s)

Diagnostic Hybrids Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →