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Recall Observatory FDA recall evidence

Device product

ORAcollect RNA: ORE-100

Z-0982-2022

February 18, 2022

Class II

Product summary

Firm
DNA Genotek Inc.
Event
Event 89831
Status
Ongoing
Classification
Class II
Quantity
17,080 (US: 14, 17,066)
Official record key
device-enforcement:Z-0982-2022

Official wording

Reason: Evaporation of stabilizing liquid reducing shelf life.

Code information: Lot: YJ530

Distribution pattern: 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, Croatia Denmark, Finland, Germany, Great Britain, Italy, Japan, Netherlands, South Africa, and Thailand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Evaporation of stabilizing liquid reducing shelf life.