FDA-Device2016-05-25Class II

Diamedix Is-CMV IgG Test Kit

Diamedix Corporation
Hazard

Product contained an incorrect substrate.

Sold states
AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico.
Affected count
150 kits
Manufactured in
14100 Nw 57th Ct, N/A, Miami Lakes, FL, United States
Products
Diamedix Is-CMV IgG Test Kit

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1689-2016

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