ORAcollect RNA: ORE-100
This recall is currently active, issued February 18, 2022. It was issued by 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)
- Official Source
- View on FDA website ↗
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.