Medical device recalls Moderate risk

DNA Genotek Inc. recalls ORAcollect RNA: ORE-100

Recall date
February 18, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0982-2022
FDA classification
Class II
Brand / firm
DNA Genotek Inc.
Sold / distributed
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WI and the countries of Australia Belgium, Brazil, Canada, Chile, China,…

Why it was recalled

Evaporation of stabilizing liquid reducing shelf life.

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

What was recalled

ORAcollect RNA: ORE-100

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