Medical device recalls Moderate risk

Diamedix Corporation recalls Diamedix Is-CMV IgG Test Kit

Recall date
March 26, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1689-2016
FDA classification
Class II
Brand / firm
Diamedix Corporation
Sold / distributed
AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico.

Why it was recalled

Product contained an incorrect substrate.

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

What was recalled

Diamedix Is-CMV IgG Test Kit

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