Diagnostic Hybrids, Inc. recalls MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in s…

Recall date

July 14, 2016

Source

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

Recall number

Z-1797-2018

FDA classification

Class II

Brand / firm

Diagnostic Hybrids, Inc.

Sold / distributed

The products were distributed to the following US states: CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, and WI. The products were distributed to the following foreign countries: Australia, Brazil, Canada, China, Costa Rica, India, Japan, Mexico, The Philippines, Russia, South Korea, South Africa, Swi…

Why it was recalled

There is a possibility of low volume and/or leaking standard bottles.

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 BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.