RecallDepth

ORAcollect RNA: ORE-100

Company
Dna Genotek Inc. 3000-500 Palladium Dr Kanata Canada
Recall Initiated
February 18, 2022
Recall Number
Z-0982-2022
Quantity
17,080 (US: 14, 17,066)

Reason for Recall

Evaporation of stabilizing liquid reducing shelf life.

Distribution

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.

Lot / Code Info

Lot: YJ530

Root Cause

Nonconforming Material/Component

Action Taken

Notification emailed to customers 2/18/2022. The shelf-life "Collect sample by/Use by" date found on the collection device tube label has been reduced by 12 months. Contact firm if unable to recover the minimum input volume required for sample extraction. Submit online acknowledgement form and contact your DNA Genotek Account manager or Technical Services with questions: support@dnagenotek.com.

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